Back to resultsInternational Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) (ISCHEMIA)
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cardiac catheterization
coronary artery bypass graft surgery
percutaneous coronary intervention
Lifestyle
Medication
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
- At least moderate ischemia on a qualifying stress test
- Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- Participant is willing to give written informed consent
- Age ≥ 21 years
Exclusion Criteria:
- LVEF < 35%
- History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
- Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
- Coronary anatomy unsuitable for either PCI or CABG
- Unacceptable level of angina despite maximal medical therapy
- Very dissatisfied with medical management of angina
- History of noncompliance with medical therapy
- Acute coronary syndrome within the previous 2 months
- PCI within the previous 12 months
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
- History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
- NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
- Non-ischemic dilated or hypertrophic cardiomyopathy
- End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
- Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
- Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
- Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
- Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
- Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
- Enrolled in a competing trial that involves a non-approved cardiac drug or device
- Inability to comply with the protocol
- Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
- Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
- Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
- High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
- Cardiac transplant recipient
- Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)
Sites / Locations
- UAB Vascular Biology and Hypertension Program
- Yuma Regional Medical Center
- Cedars Sinai Medical Center
- UCSF - Fresno Community Regional Medical Center
- Ronald Reagan UCLA Medical Center
- University of California Irvine Medical Center
- Palo Alto Medical Foundation Research Institute
- VA Palo Alto HealthCare System
- Kaiser Permanente San Jose
- Coastal Heart Medical Group
- Stanford University School of Medicine
- Torrance Memorial Medical Center
- South Denver Cardiology Associates, P.C.
- Medical Center of the Rockies
- VA Connecticut Healthcare System
- Daytona Heart Group
- Malcom Randall VAMC
- Mayo Clinic Florida
- Cardiovascular Center of Sarasota
- Sarasota Memorial Hospital
- University of South Florida
- Emory University
- Atlanta VA Medical Center
- Advanced Heart Care Group
- Loyola University Medical Center
- Indiana University/Krannert Institute of Cardiology
- Midwest Cardiovascular Research Foundation
- University of Iowa Hospitals and Clinics
- University of Kentucky
- Lexington VA Medical Center
- University of Louisville
- Cardiovascular Specialists of Southwest Louisiana
- University of Maryland Medical Center
- NIH Heart Center at Suburban Hospital
- Walter Reed National Military Medical Center
- Brigham & Women's Hospital, Harvard Medical School
- Boston Medical Center
- VA Boston Healthcare System
- Saint Vincent Hospital at Worcester Medical Center
- Henry Ford Health System
- Spectrum Health
- Covenant Medical Center, Inc.
- Providence - Providence Park Hospital
- Michigan Heart, PC
- Minneapolis VAMC
- University of Minnesota
- Mayo Clinic
- HealthEast Saint Joseph's Hospital
- Saint Luke's Hospital
- Kansas City VA Medical Center
- Englewood Hospital and Medical Center
- AtlantiCare Regional Medical Center
- Hackensack University Medical Center
- Albany Medical Center Hospital
- Samuel Stratton VA Medical Center of Albany NY
- Capital Cardiology Associates
- NYU-HHC Lincoln Medical and Mental Health Center
- Jacobi Medical Center
- NYU-HHC Kings County Hospital Center
- New York -Presbyterian/Brooklyn Methodist Hospital
- NYU-HHC Woodhull Hospital
- Coney Island Hospital
- NYP Medical Medical Group Hudson Valley Cardiology
- New York University - Langone Cardiovascular Associates
- Mid Valley Cardiology
- Northwell Health - Manhasset
- NYU Winthrop
- VA New York Harbor Health Care System
- Beth Israel Medical Center
- NYU Langone Medical Center-Bellevue Hospital
- NYU New York Medical Associates
- Mount Sinai Saint Luke's Hospital
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center
- University of Rochester
- Cardiology Associates of Schenectady P.C.
- Asheville Cardiology Associates
- Duke University Medical Center
- Sanford Health
- Cincinnati VA Medical Center
- Louis Stokes Cleveland Veterans Affairs Medical Center
- Ohio Health Grant Medical Center
- Oklahoma Heart Institute
- Oregon Health & Science University
- Providence Heart and Vascular Institute
- Saint Luke's Hospital and Health Network
- Holy Spirit Hospital Cardiovascular Institute
- Doylestown Health Cardiology
- Conemaugh Valley Memorial Hospital
- Miriam Hospital
- Kent Hospital
- Vanderbilt University Medical Center
- Saint Thomas Hospital
- V.A. North Texas Health Care System
- Baylor College of Medicine
- Baylor St. Luke's Medical Center
- Houston Heart & Vascular Associates
- Baylor Research Institute at Legacy Heart Center
- The Heart Hospital Baylor
- Audie Murphy V.A.
- Medicus Alliance Clinical Research Org., Inc.
- Wichita Falls Heart Clinic
- Salt Lake City VA Medical Center
- VAMC-White River Junction
- Cardiovascular Associates, Ltd.
- Stroobants Cardiovascular Center
- Winchester Cardiology and Vascular Medicine, PC
- University of Washington Medical Center
- Gundersen Lutheran Medical Center
- Hospital Italiano Regional del Sur Bahia Blanca
- Fundacion Favaloro
- Instituto Medico DAMIC
- Clinica Del Prado
- Clinica Romagosa and Clinica De La Familia
- Clínica Privada Vélez Sarsfield
- John Hunter Hospital
- Flinders Medical Centre
- The Queen Elizabeth Hospital
- Royal Perth Hospital
- LKH Graz West Austria
- Medical University of Vienna, Department of Cardiology
- Wilhelminen Hospital Vienna
- University Hospital Leuven
- Fundacao Bahiana de Cardilogia
- Hospital Lifecenter
- Hospital Maternidade e Pronto Socorro Santa Lucia
- Quanta Diagnostico & Terapia
- Hospital Cardiologico Costantini
- Hospital Pró-Cardíaco
- Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
- Instituto de Cardiologia de Porto Alegre
- Hospital Sao Vicente de Paulo
- Hospital de Clinicas de Porto Alegre
- Instituto Dante Pazzanese de Cardiologia
- Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
- Hospital TotalCor
- Hospital da Bahia
- Unifesp - Hospital Sao Paulo
- Heart Institute (InCor) University of São Paulo
- Hospital Celso Pierro
- University of Calgary
- University of Alberta
- Vancouver General Hospital
- West Lincoln Memorial Hospital
- Hamilton General Hospital
- London Health Sciences Centre
- Dixie Medical Group
- Dr. James Cha
- Scarborough Cardiology Research
- Saint Catharines General Hospital
- St. Michael's Hospital
- Women's College Hospital
- University Health Network
- Northwest GTA Cardiovascular and Heart Rhythm Program
- Montreal Heart Institute
- Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal
- CISSSL - Hopital Pierre-Le Gardeur
- Centre Hospitalier de Regional Trois-Rivieres
- University of Ottawa Heart Institute
- Beijing Chao-yang Hospital, Capital Medical University
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Peking Union Medical College Hospital
- Beijing Anzhen Hospital
- Liangxiang Hospital, Beijing Fangshan District
- Guangdong General Hospital
- Tangshan Gongren Hospital
- The Second Affiliated Hospital of Zhengzhou University
- The First Affiliated Hospital of Zhengzhou University
- Tongji Medical College
- Wuhan Asia Heart Hospital
- Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
- Affiliated Zhongshan Hospital of Dalian University
- Affiliated Hospital of Jining Medical University
- Qingdao Fuwai Hospital
- Shanxi Cardiovascular Hospital
- Shanxi Provincial People's Hospital
- TEDA International Cardiovascular Hospital
- First Affiliated Hospital of Xinjiang Medical University
- The Second Affiliated Hospital Zhejiang University School of Medicine
- Cairo University
- C.H. Louis Pasteur
- Ambroise Pare Hospital
- Centre Hospitalier Sud Francilien
- Antoine-Beclere Hospital
- Bichat Hospital
- Grenoble University Hospital
- Centre Hospitalier Universitaire d'Angers
- Robert-Bosch-Krankenhaus
- Universitatsklinikum Bonn
- Praxisklinik Herz Und Gefaesse
- University Hospital Jena
- University of Szeged
- Eszszk- Szent Istvan Hospital
- Military Hospital, Budapest
- Heart and Vascular Center, Semmelweis University
- George Gottsegen National Institute of Cardiology
- CARE Hospital
- Gurunanak CARE Hospital
- Dr Ram Manohar Lohia Hospital
- Fortis Escort Heart Institute
- Batra Hospital and Medical Research Centre (BHMRC)
- Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
- Sri Jayadeva Institute of Cardiovascular Sciences and Research
- Government Medical College
- MOSC Medical College Hospital, Kolenchery
- Sree Chitra Tirunal Institute for Medical Sciences and Technology
- Ruby Hall Clinic,Grant Medical Foundation
- KEM Hospital Pune
- Hero DMC Heart Institute, Dayanand Medical College and Hospital
- Apollo Research and Innovation
- Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
- CARE Nampally
- Apollo Research & Innovations
- King George's Medical University, Department of Cardiology
- All India Institute of Medical Sciences
- Rambam Medical Center
- Assuta Medical Centers
- AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"
- Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)
- IRCCS "Casa Sollievo della Sofferenza"
- Cardiology and CCU - Ospedali Riuniti Ancona
- Policlinico di Monza, Monza MB
- Humanitas Research Hospital, Rozzano (MI)
- Azienda Ospedaliera S. Croce e Carle
- UO Cardiologia Ospedale SS Cosma e Damiano
- Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli
- University of Padua- Cardiology Clinic
- Ospedale Regionale Umberto Parini
- Clinica Mediterranea
- Ospedale di Circolo e Fondazione Macchi
- National Cerebral and Cardiovascular Center
- Saitama Medical University
- Keio University Hospital
- Vilnius University Hospital Santariskes Clinic
- Institut Jantung Negara
- Instituto Mexicano del Seguro Social
- Instituto Nacional de Cardiología "Ignacio Chávez"
- Cardio Research Hartcentrum OLVG
- Radboudumc
- Isala Klinieken
- Waikato Hospital
- Auckland City Hospital
- University Clinic of Cardiology
- Instituto Neuro Cardiovascular De Las Americas
- T.Marciniak Hospital
- Cardiology Clinic, Medical University in Lodz
- Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College
- Institute of Cardiology, Warsaw
- Coronary and Structural Heart Diseases Department, Institute of Cardiology
- Department of Interventional Cardiology & Angiology, Institute of Cardiology
- Medical University of Warsaw
- Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw
- University Hospital in Bialystok
- Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases
- Szpital Kliniczny Przemienienia Pańskiego
- Military Hospital / Medical University
- Hospital de Santa Marta
- Santa Maria University Hospital, Cardiology Department, CHLN
- Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
- Emergency County Hospital Baia Mare
- Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''
- National Medical Research Center for Cardiovascuar Surgery
- E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
- North-Western State Medical University
- Federal Almazov North-West Medical Research Centre
- King AbdulAziz Cardiac Center
- Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad
- Clinical Center of Serbia
- Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia
- University Clinical Hospital Zvezdara
- University Hospital Center Bezanijska Kosa
- Clinical Center Kragujevac
- Clinic for Cardiovascular Diseases, Clinical Center Nis
- National University Heart Center Singapore
- National Heart Centre Singapore
- Tan Tock Seng Hospital
- Groote Schuur Hospital / University of Cape Town
- Hospital Clinico Universitario de Santiago
- Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain
- Hospital de la Santa Creu i Sant Pau
- Hospital De Bellvitge
- Hospital General Universitario Gregorio Maranon
- Hospital La Paz. IdiPaz
- HUVA, Hospital Clínico Universitario Virgen De La Arrixaca
- Hospital Universitario y Politecnico La Fe
- Hospital Universitario Miguel Servet
- Karolinska Institutet at Danderyd Hospital
- Uppsala University
- Cardiocentro
- Mackay Memorial Hospital
- Maharaj Nakorn Chiang Mai Hospital
- Ramathibodi Hospital
- Belfast Trust
- Bedford Hospital NHS Trust
- Luton and Dunstable University Hospital NHS FT
- Papworth Hospital
- Peterborough City Hospital
- The James Cook University Hospital, Middlesbrough
- Royal Bournemouth Hospital
- Dorset County Hospital
- The University of Hull/Castle Hill Hospital
- Broomfield Hospital
- Southend University Hospital
- Hampshire Hospitals NHS Foundation Trust
- Blackpool Teaching Hospitals
- The Pennine Acute Hospitals NHS Trust
- Northwick Park Hospital Harrow/ Royal Brompton Hospital London
- South Eastern Health and Social Care
- Cardiovascular Research Unit, Craigavon Area Hospital
- Nottingham University Hospitals
- Royal Infirmary of Edinburgh
- University of Glasgow
- Russells Hall Hospital
- Bradford Royal Infirmary
- Pinderfields Hospital
- University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust
- Royal Free London NHS Foundation Trust
- King's College NHS Foundation Hospital
- Imperial College Healthcare NHS Trust
- Central Manchester University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Invasive Strategy (INV)
Conservative Strategy
Arm Description
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Outcomes
Primary Outcome Measures
Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Number of Participants That Experienced Death From Any Cause
Cumulative Event Rate of Death From Any Cause
Number of Participants That Experienced Myocardial Infarction
Cumulative Event Rate of Myocardial Infarction
Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
Secondary Outcome Measures
Full Information
NCT ID
NCT01471522
First Posted
November 10, 2011
Last Updated
May 30, 2023
Sponsor
NYU Langone Health
Collaborators
New York University, Stanford University, National Heart, Lung, and Blood Institute (NHLBI), Albany Stratton VA Medical Center, Cedars-Sinai Medical Center, Columbia University, Duke University, East Carolina University, Emory University, Harvard University, Massachusetts General Hospital, Montreal Heart Institute, University of British Columbia, University of Missouri, Kansas City, Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT01471522
Brief Title
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Acronym
ISCHEMIA
Official Title
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
New York University, Stanford University, National Heart, Lung, and Blood Institute (NHLBI), Albany Stratton VA Medical Center, Cedars-Sinai Medical Center, Columbia University, Duke University, East Carolina University, Emory University, Harvard University, Massachusetts General Hospital, Montreal Heart Institute, University of British Columbia, University of Missouri, Kansas City, Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.
SPECIFIC AIMS
A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.
B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.
Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH
Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH
Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH
Detailed Description
BACKGROUND:
Evidence supporting a routine invasive practice paradigm for patients with SIHD is outdated. In strategy trials conducted in the 1970s, coronary artery bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with high-risk anatomic features. The relevance of these studies today is speculative because contemporary secondary prevention-aspirin, beta-blockers, statins, ACE inhibitors, and lifestyle interventions-were used minimally if at all. Subsequent trials have compared percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical therapy in SIHD patients, found that among patients selected on the basis of coronary anatomy after cardiac catheterization, an initial management strategy of coronary revascularization (PCI, PCI or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine cardiac catheterization--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had ischemia severity documented at baseline had only mild or moderate ischemia, leaving open the question of the appropriate role of cardiac catheterization and revascularization among higher-risk patients with more severe ischemia. Observational data suggest that revascularization of patients with moderate-to-severe ischemia is associated with a lower mortality than medical therapy alone, but such data cannot establish a cause and effect relationship. In clinical practice only about half such patients are referred for cardiac catheterization, indicating equipoise. Furthermore, analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline did not reveal a benefit from PCI. This issue cannot be resolved using available data because all prior SIHD strategy trials enrolled patients after cardiac catheterization, introducing undefined selection biases (e.g., highest risk patients not enrolled) and making translation of study results problematic for clinicians managing patients who have not yet had cardiac catheterization.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been performed before COURAGE and BARI 2D results were available) is needed to inform optimal management for such patients.
DESIGN NARRATIVE, INCLUDING MODIFICATIONS DURING THE TRIAL
Primary Endpoint
A composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure was proposed as the primary endpoint in the application that was funded by NLHBI, with a secondary endpoint of CV death or MI. Study protocol version 1.0 was finalized on January 18, 2012 after review and approval by the protocol review committee (DSMB) with the primary endpoint specified as the composite of CV death or MI. Regarding the final status of the primary endpoint, the protocol stated:
"To ensure that the primary analysis is well-powered and useful, a prospective plan to allow extending follow-up and/or changing the primary endpoint based on aggregate event rate data will be established prior to the first review of unblinded trial data. At a designated time during the trial, an analysis will be conducted to estimate the overall aggregate primary endpoint event rate and project the final number of observed events. If the estimated unconditional power (i.e. based on aggregate event rate data; not by treatment group) is less than the originally targeted 90%, then one or more of the following options will be considered:
Extend follow-up to allow more events to accrue.
Change the primary endpoint to one that occurs more frequently. The current primary endpoint would become a secondary endpoint. The proposed new primary endpoint would be the composite of CV death, MI, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.
Follow the recommendation of an independent advisory panel. An independent advisory panel, separate from the DSMB, will be convened for the purpose of reviewing unconditional power estimates and making a recommendation to the NHLBI Director. Members of this panel will not have access to unblinded data by treatment group or other data that may bias their recommendation." All 5 event types were adjudicated throughout the trial. Study protocol v2.0 (January 2014) allowed ischemia eligibility by non-imaging exercise stress test if more stringent (≥70% stenosis) CCTA criteria were met. The 2016 protocol addendum describes the NHLBI-approved reduction in sample size and extension of recruitment and follow-up due to slower than projected recruitment.
The pre-specified first analysis for monitoring and projecting the final aggregate number of primary endpoint events was conducted in 2015. In 2016, the projected need to increase the power by extending follow-up and elevating the 5-component secondary endpoint to become primary was discussed at Steering Committee and Investigator meetings and communicated by email.
An Independent Advisory Panel convened by NHLBI met in May 2017, and in June 2017 NHLBI approved the Independent Advisory Panel's recommendation to elevate the 5-component secondary endpoint to become primary and retain the 2-component composite as a key secondary endpoint. The panel also recommended extension of follow-up. This was communicated to the Steering Committee and Investigators at August and November 2017 meetings and by email. The last visit date was June 30, 2019.
A statistical plan developed for the Independent Advisory Panel process in 2012 specified that a decision about changing the primary endpoint would be targeted to occur before 75% of the final number of primary endpoint events had accrued. Although the final number of primary endpoint events was unknown during the course of the trial, estimates performed at the time of the Advisory Panel meeting suggested that the ratio of accrued endpoint events to final endpoint events was below 50%. See Maron DJ et al. Am Heart J. 2018 201:124-135. PMC6005768 for additional details about modifications to the trial while it was being conducted.
Analysis of Patients' Health Status as a Key Secondary Endpoint
A key secondary objective of the ISCHEMIA trial is to compare the quality of life outcomes-patients' symptoms, functioning and well-being-between those assigned to an invasive strategy as compared with a conservative strategy. In the protocol, angina frequency and disease-specific quality of life measured by the Seattle Angina Questionnaire (SAQ) Angina Frequency and Quality of Life scales, respectively, are described as the tools that will be used to make this comparative assessment. Recent work has indicated that it is possible to combine the information from the individual domain scores in the SAQ into a new Summary Score that captures the information from the SAQ Angina Frequency, Physical Limitation and Quality of Life scales into a single overall score. The advantages of using a summary score as the primary measure of QOL effects of a therapy are a single primary endpoint comparison rather than two or three (eliminating concerns some may have about multiple comparisons) and a more intuitive holistic (patient-centric) interpretation of the effectiveness results. With these advantages in mind, the ISCHEMIA leadership has agreed that the SAQ Summary Score will be designated as the primary way this outcome for this key secondary endpoint of the ISCHEMIA trial will be analyzed and interpreted, with the individual SAQ scores being used in a secondary, explanatory and descriptive role.
PARTICIPATING COUNTRIES:
North America:
Canada; Mexico; USA
South America:
Argentina; Brazil; Peru
Asia:
China; India; Japan; Malaysia; Singapore; Taiwan; Thailand; Russian Federation
Pacifica:
Australia; New Zealand
Europe:
Austria; Belgium; France; Germany; Hungary; Italy; Lithuania; Macedonia; Netherlands; Poland; Portugal; Romania; Serbia; Spain; Sweden; Switzerland; UK
Middle East:
Egypt; Israel; Saudi Arabia
Africa:
South Africa
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Invasive Strategy (INV)
Arm Type
Active Comparator
Arm Description
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.
Arm Title
Conservative Strategy
Arm Type
Active Comparator
Arm Description
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.
Intervention Type
Procedure
Intervention Name(s)
cardiac catheterization
Other Intervention Name(s)
cath
Intervention Description
Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
Intervention Type
Procedure
Intervention Name(s)
coronary artery bypass graft surgery
Other Intervention Name(s)
CABG
Intervention Description
Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention
Other Intervention Name(s)
PCI
Intervention Description
Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Other Intervention Name(s)
Behavior change
Intervention Description
diet, physical activity, smoking cessation
Intervention Type
Drug
Intervention Name(s)
Medication
Other Intervention Name(s)
Pharmacologic Therapy
Intervention Description
antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
Primary Outcome Measure Information:
Title
Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
Time Frame
3.2 year follow-up (median)
Title
Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
Description
This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Time Frame
5 years
Title
Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
Time Frame
5 years
Title
Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
Description
This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Time Frame
5 years
Title
Number of Participants That Experienced Death From Any Cause
Time Frame
5 years
Title
Cumulative Event Rate of Death From Any Cause
Time Frame
5 years
Title
Number of Participants That Experienced Myocardial Infarction
Time Frame
5 years
Title
Cumulative Event Rate of Myocardial Infarction
Time Frame
5 years
Title
Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
Description
The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
Time Frame
5 years
Title
Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
Time Frame
5 years
Title
Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
Time Frame
5 years
Title
Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least moderate ischemia on a qualifying stress test
Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
Participant is willing to give written informed consent
Age ≥ 21 years
Exclusion Criteria:
LVEF < 35%
History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available)
Finding of "no obstructive CAD" (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months
Coronary anatomy unsuitable for either PCI or CABG
Unacceptable level of angina despite maximal medical therapy
Very dissatisfied with medical management of angina
History of noncompliance with medical therapy
Acute coronary syndrome within the previous 2 months
PCI within the previous 12 months
Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia not due to a transient reversible cause
NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months
Non-ischemic dilated or hypertrophic cardiomyopathy
End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min (not an exclusion criterion for CKD ancillary trial, see CKD ancillary trial, Section 18)
Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast
Planned major surgery necessitating interruption of dual antiplatelet therapy (note that patients may be eligible after planned surgery)
Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)
Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab)
Enrolled in a competing trial that involves a non-approved cardiac drug or device
Inability to comply with the protocol
Exceeds the weight or size limit for CCTA or cardiac catheterization at the site
Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern
Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
High risk of bleeding which would contraindicate the use of dual antiplatelet therapy
Cardiac transplant recipient
Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith S Hochman, MD
Organizational Affiliation
New York University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David J Maron, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Vascular Biology and Hypertension Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCSF - Fresno Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94087
Country
United States
Facility Name
VA Palo Alto HealthCare System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94550
Country
United States
Facility Name
Kaiser Permanente San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Coastal Heart Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
South Denver Cardiology Associates, P.C.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06111
Country
United States
Facility Name
Daytona Heart Group
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Malcom Randall VAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Cardiovascular Center of Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Advanced Heart Care Group
City
Fairview Heights
State/Province
Illinois
ZIP/Postal Code
62208
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University/Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Lexington VA Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
42503
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Cardiovascular Specialists of Southwest Louisiana
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
NIH Heart Center at Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Brigham & Women's Hospital, Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
VA Boston Healthcare System
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Saint Vincent Hospital at Worcester Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Covenant Medical Center, Inc.
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
01876
Country
United States
Facility Name
Providence - Providence Park Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Michigan Heart, PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
HealthEast Saint Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
Hackensack University Medical Center
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Samuel Stratton VA Medical Center of Albany NY
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Capital Cardiology Associates
City
Albany
State/Province
New York
ZIP/Postal Code
12211
Country
United States
Facility Name
NYU-HHC Lincoln Medical and Mental Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU-HHC Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York -Presbyterian/Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
NYU-HHC Woodhull Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Coney Island Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
NYP Medical Medical Group Hudson Valley Cardiology
City
Cortlandt Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Facility Name
New York University - Langone Cardiovascular Associates
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Mid Valley Cardiology
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Northwell Health - Manhasset
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Winthrop
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
VA New York Harbor Health Care System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center-Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU New York Medical Associates
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Mount Sinai Saint Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cardiology Associates of Schenectady P.C.
City
Schenectady
State/Province
New York
ZIP/Postal Code
12309
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Sanford Health
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Louis Stokes Cleveland Veterans Affairs Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio Health Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Providence Heart and Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Saint Luke's Hospital and Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Holy Spirit Hospital Cardiovascular Institute
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Doylestown Health Cardiology
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Conemaugh Valley Memorial Hospital
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
373203
Country
United States
Facility Name
V.A. North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Heart & Vascular Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Baylor Research Institute at Legacy Heart Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
The Heart Hospital Baylor
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Audie Murphy V.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medicus Alliance Clinical Research Org., Inc.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Wichita Falls Heart Clinic
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Salt Lake City VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VAMC-White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Cardiovascular Associates, Ltd.
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Winchester Cardiology and Vascular Medicine, PC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
University of Washington Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Hospital Italiano Regional del Sur Bahia Blanca
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
8000
Country
Argentina
Facility Name
Fundacion Favaloro
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Instituto Medico DAMIC
City
Cordoba
State/Province
CBA
ZIP/Postal Code
5009
Country
Argentina
Facility Name
Clinica Del Prado
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Clinica Romagosa and Clinica De La Familia
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Clínica Privada Vélez Sarsfield
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
LKH Graz West Austria
City
Graz
State/Province
Stmk
ZIP/Postal Code
8020
Country
Austria
Facility Name
Medical University of Vienna, Department of Cardiology
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminen Hospital Vienna
City
Vienna
State/Province
Wien
ZIP/Postal Code
A-1160
Country
Austria
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Fundacao Bahiana de Cardilogia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41810-010
Country
Brazil
Facility Name
Hospital Lifecenter
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-921
Country
Brazil
Facility Name
Hospital Maternidade e Pronto Socorro Santa Lucia
City
Pocos de Caldas
State/Province
Minas Gerais
ZIP/Postal Code
37701-045
Country
Brazil
Facility Name
Quanta Diagnostico & Terapia
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80045-170
Country
Brazil
Facility Name
Hospital Cardiologico Costantini
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80320-320
Country
Brazil
Facility Name
Hospital Pró-Cardíaco
City
Botafogo
State/Province
Rio De Janeiro
ZIP/Postal Code
22280-020
Country
Brazil
Facility Name
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sol
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Instituto de Cardiologia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Fundo
State/Province
RS
ZIP/Postal Code
99010080
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Ibirapuera
State/Province
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital TotalCor
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
1418100
Country
Brazil
Facility Name
Hospital da Bahia
City
Salvador
ZIP/Postal Code
BA, 41820-011
Country
Brazil
Facility Name
Unifesp - Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04025-011
Country
Brazil
Facility Name
Heart Institute (InCor) University of São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital Celso Pierro
City
Sao Paulo
ZIP/Postal Code
13059-740
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
West Lincoln Memorial Hospital
City
Grimsby
State/Province
Ontario
ZIP/Postal Code
L3M 1P3
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Dixie Medical Group
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 0C2
Country
Canada
Facility Name
Dr. James Cha
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Scarborough Cardiology Research
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 5E9
Country
Canada
Facility Name
Saint Catharines General Hospital
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S0A9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Northwest GTA Cardiovascular and Heart Rhythm Program
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4H0P6
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux du Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CISSSL - Hopital Pierre-Le Gardeur
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Facility Name
Centre Hospitalier de Regional Trois-Rivieres
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Beijing Chao-yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Chinese Academy of Medical Sciences, Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Chaoyang
ZIP/Postal Code
100029
Country
China
Facility Name
Liangxiang Hospital, Beijing Fangshan District
City
Beijing
State/Province
Fangshan
ZIP/Postal Code
102401
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
Facility Name
Tangshan Gongren Hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Tongji Medical College
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan Union Hospital, Tongji Medical College, Huazhong Science and Tech University
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
Qingdao Fuwai Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
TEDA International Cardiovascular Hospital
City
Tianjing
State/Province
Tianjing
ZIP/Postal Code
300457
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Name
C.H. Louis Pasteur
City
Chatres
State/Province
Centre
ZIP/Postal Code
28018
Country
France
Facility Name
Ambroise Pare Hospital
City
Boulogne
State/Province
Ile De France
ZIP/Postal Code
92100
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes cedex
State/Province
Ile De France
ZIP/Postal Code
91100
Country
France
Facility Name
Antoine-Beclere Hospital
City
Clamart Cedex
State/Province
Ile-de-France
ZIP/Postal Code
92141
Country
France
Facility Name
Bichat Hospital
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75018
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers Cedex 9
State/Province
Pays De La Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
State/Province
BW
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
State/Province
NRW
ZIP/Postal Code
53105
Country
Germany
Facility Name
Praxisklinik Herz Und Gefaesse
City
Dresden
State/Province
Saxony
ZIP/Postal Code
D-01099
Country
Germany
Facility Name
University Hospital Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
University of Szeged
City
Szeged
State/Province
Szeged Megyei Varos
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Eszszk- Szent Istvan Hospital
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Military Hospital, Budapest
City
Budapest
ZIP/Postal Code
1117
Country
Hungary
Facility Name
Heart and Vascular Center, Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
George Gottsegen National Institute of Cardiology
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
Facility Name
CARE Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Gurunanak CARE Hospital
City
Hyderabad
State/Province
AP
ZIP/Postal Code
500020
Country
India
Facility Name
Dr Ram Manohar Lohia Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Fortis Escort Heart Institute
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110025
Country
India
Facility Name
Batra Hospital and Medical Research Centre (BHMRC)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110062
Country
India
Facility Name
Fortis Healthcare Fl.t Lt. Rajan Dhall Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Sri Jayadeva Institute of Cardiovascular Sciences and Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560069
Country
India
Facility Name
Government Medical College
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673008
Country
India
Facility Name
MOSC Medical College Hospital, Kolenchery
City
Kolenchery
State/Province
Kerala
ZIP/Postal Code
682311
Country
India
Facility Name
Sree Chitra Tirunal Institute for Medical Sciences and Technology
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Ruby Hall Clinic,Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
KEM Hospital Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Hero DMC Heart Institute, Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Apollo Research and Innovation
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600081
Country
India
Facility Name
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
City
Pondicherry
State/Province
Tamil Nadu
ZIP/Postal Code
605006
Country
India
Facility Name
CARE Nampally
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500001
Country
India
Facility Name
Apollo Research & Innovations
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
600081
Country
India
Facility Name
King George's Medical University, Department of Cardiology
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Assuta Medical Centers
City
Tel-Aviv
ZIP/Postal Code
67891
Country
Israel
Facility Name
AORN Dei Colli "V. Monaldi" UOC Cardiologia Università della Campania "L.Vanvitelli"
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale "G.B. Morgagni - L. Pierantoni" Forli (AUSL della Romagna)
City
Forli
State/Province
Emilia-Romagna
ZIP/Postal Code
47100
Country
Italy
Facility Name
IRCCS "Casa Sollievo della Sofferenza"
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Cardiology and CCU - Ospedali Riuniti Ancona
City
Ancona
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
Policlinico di Monza, Monza MB
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Humanitas Research Hospital, Rozzano (MI)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
UO Cardiologia Ospedale SS Cosma e Damiano
City
Pescia
State/Province
Tuscany
ZIP/Postal Code
54100
Country
Italy
Facility Name
Azienda Servizi Sanitaria n.3 Alto Friuli-Collinare-Medio Friuli
City
Tolmezzo
State/Province
Udine
ZIP/Postal Code
33028
Country
Italy
Facility Name
University of Padua- Cardiology Clinic
City
Padua
State/Province
Veneto
ZIP/Postal Code
35100
Country
Italy
Facility Name
Ospedale Regionale Umberto Parini
City
Aosta
ZIP/Postal Code
11100
Country
Italy
Facility Name
Clinica Mediterranea
City
Naples
ZIP/Postal Code
80121
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Saitama Medical University
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Vilnius University Hospital Santariskes Clinic
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Instituto Mexicano del Seguro Social
City
Benito Juarez
State/Province
DF
ZIP/Postal Code
3100
Country
Mexico
Facility Name
Instituto Nacional de Cardiología "Ignacio Chávez"
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Cardio Research Hartcentrum OLVG
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
University Clinic of Cardiology
City
Skopje
State/Province
Republic Of Macedo
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Instituto Neuro Cardiovascular De Las Americas
City
Miraflores
State/Province
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
T.Marciniak Hospital
City
Wrocław
State/Province
Dolny Śląsk
ZIP/Postal Code
54-090
Country
Poland
Facility Name
Cardiology Clinic, Medical University in Lodz
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Department of Coronary Disease, John Paul II Hospital, Jagiellonian University Medical College
City
Krakow
State/Province
Maopolskie
ZIP/Postal Code
31-200
Country
Poland
Facility Name
Institute of Cardiology, Warsaw
City
Warsaw
State/Province
Mazovian
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Coronary and Structural Heart Diseases Department, Institute of Cardiology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Department of Interventional Cardiology & Angiology, Institute of Cardiology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
PL-02-097
Country
Poland
Facility Name
Department of Internal Medicine and Cardiology, Infant Jesus Teaching Hospital, Medical University of Warsaw
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-005
Country
Poland
Facility Name
University Hospital in Bialystok
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Medical University of Silesia, School of Medicine with the Division of Dentistry, Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases
City
Zabrze
State/Province
Wojewodztwo Slaskie
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Pańskiego
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Military Hospital / Medical University
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Hospital de Santa Marta
City
Lisboa
ZIP/Postal Code
1150-291
Country
Portugal
Facility Name
Santa Maria University Hospital, Cardiology Department, CHLN
City
Lisbon
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Emergency County Hospital Baia Mare
City
Baia Mare
ZIP/Postal Code
021967
Country
Romania
Facility Name
Emergency Institute of Cardiovascular Diseases ''Prof. Dr. C. C. Iliescu''
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
National Medical Research Center for Cardiovascuar Surgery
City
Moscow
State/Province
Gorod Moskva
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
North-Western State Medical University
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Federal Almazov North-West Medical Research Centre
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
King AbdulAziz Cardiac Center
City
Riyadh
State/Province
Central Province
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia and Faculty of Medicine, University of Novi Sad
City
Sremska Kamenica
State/Province
Vojvodina
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Faculty of Medicine, University of Belgrade; Cardiology Clinic, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Hospital Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Cardiovascular Diseases, Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
National University Heart Center Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Groote Schuur Hospital / University of Cape Town
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7945
Country
South Africa
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas, Department of Cardiology. INIBIC A Coruña. CIBER-CV. Universidad de A Coruña, Spain
City
A Coruna
ZIP/Postal Code
15008
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital De Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital La Paz. IdiPaz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
HUVA, Hospital Clínico Universitario Virgen De La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Karolinska Institutet at Danderyd Hospital
City
Stockholm
ZIP/Postal Code
S-18288
Country
Sweden
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Cardiocentro
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Mackay Memorial Hospital
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
State/Province
Meung
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Belfast Trust
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Bedford Hospital NHS Trust
City
Bedford
State/Province
Bedfordshire
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Facility Name
Luton and Dunstable University Hospital NHS FT
City
Luton
State/Province
Berdfordshire
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
State/Province
Cambs
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
The James Cook University Hospital, Middlesbrough
City
Middlesbrough
State/Province
Cleveland
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
The University of Hull/Castle Hill Hospital
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Southend University Hospital
City
Westcliff-on-Sea
State/Province
Essex
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Hampshire Hospitals NHS Foundation Trust
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Blackpool Teaching Hospitals
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
The Pennine Acute Hospitals NHS Trust
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Northwick Park Hospital Harrow/ Royal Brompton Hospital London
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
South Eastern Health and Social Care
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Cardiovascular Research Unit, Craigavon Area Hospital
City
Craigavon
State/Province
Northern Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
State/Province
Notts
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
University of Glasgow
City
Clydebank
State/Province
Strathclyde
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Wakefield
State/Province
West Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust/Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College NHS Foundation Hospital
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12OHS
Country
United Kingdom
Facility Name
Central Manchester University Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be submitted to the NHLBI according to their guidelines within 3 years after the final patient follow-up (June 30, 2019) or 2 years after the main paper of the trial has been published, whichever comes first.
IPD Sharing Time Frame
June 2022
Citations:
PubMed Identifier
22137077
Citation
Maron DJ, Stone GW, Berman DS, Mancini GB, Scott TA, Byrne DW, Harrell FE Jr, Shaw LJ, Hachamovitch R, Boden WE, Weintraub WS, Spertus JA. Is cardiac catheterization necessary before initial management of patients with stable ischemic heart disease? Results from a Web-based survey of cardiologists. Am Heart J. 2011 Dec;162(6):1034-1043.e13. doi: 10.1016/j.ahj.2011.09.001.
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Phillips LM, Hachamovitch R, Berman DS, Iskandrian AE, Min JK, Picard MH, Kwong RY, Friedrich MG, Scherrer-Crosbie M, Hayes SW, Sharir T, Gosselin G, Mazzanti M, Senior R, Beanlands R, Smanio P, Goyal A, Al-Mallah M, Reynolds H, Stone GW, Maron DJ, Shaw LJ. Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA. J Nucl Cardiol. 2013 Dec;20(6):969-75. doi: 10.1007/s12350-013-9773-4.
Results Reference
background
PubMed Identifier
29778671
Citation
ISCHEMIA Trial Research Group; Maron DJ, Hochman JS, O'Brien SM, Reynolds HR, Boden WE, Stone GW, Bangalore S, Spertus JA, Mark DB, Alexander KP, Shaw L, Berger JS, Ferguson TB Jr, Williams DO, Harrington RA, Rosenberg Y. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018 Jul;201:124-135. doi: 10.1016/j.ahj.2018.04.011. Epub 2018 Apr 21.
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PubMed Identifier
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Citation
Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Alexander KP, Senior R, Boden WE, Stone GW, Goodman SG, Lopes RD, Lopez-Sendon J, White HD, Maggioni AP, Shaw LJ, Min JK, Picard MH, Berman DS, Chaitman BR, Mark DB, Spertus JA, Cyr DD, Bhargava B, Ruzyllo W, Wander GS, Chernyavskiy AM, Rosenberg YD, Maron DJ; ISCHEMIA Research Group. Baseline Characteristics and Risk Profiles of Participants in the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014. Erratum In: JAMA Cardiol. 2019 May 1;4(5):497.
Results Reference
background
PubMed Identifier
36115814
Citation
Reynolds HR, Diaz A, Cyr DD, Shaw LJ, Mancini GBJ, Leipsic J, Budoff MJ, Min JK, Hague CJ, Berman DS, Chaitman BR, Picard MH, Hayes SW, Scherrer-Crosbie M, Kwong RY, Lopes RD, Senior R, Dwivedi SK, Miller TD, Chow BJW, de Silva R, Stone GW, Boden WE, Bangalore S, O'Brien SM, Hochman JS, Maron DJ; ISCHEMIA Research Group. Ischemia With Nonobstructive Coronary Arteries: Insights From the ISCHEMIA Trial. JACC Cardiovasc Imaging. 2023 Jan;16(1):63-74. doi: 10.1016/j.jcmg.2022.06.015. Epub 2022 Sep 14.
Results Reference
derived
PubMed Identifier
35981820
Citation
Garcia RA, Spertus JA, Benton MC, Jones PG, Mark DB, Newman JD, Bangalore S, Boden WE, Stone GW, Reynolds HR, Hochman JS, Maron DJ; ISCHEMIA Research Group. Association of Medication Adherence With Health Outcomes in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Aug 23;80(8):755-765. doi: 10.1016/j.jacc.2022.05.045.
Results Reference
derived
PubMed Identifier
35411785
Citation
Bangalore S, Spertus JA, Stevens SR, Jones PG, Mancini GBJ, Leipsic J, Reynolds HR, Budoff MJ, Hague CJ, Min JK, Boden WE, O'Brien SM, Harrington RA, Berger JS, Senior R, Peteiro J, Pandit N, Bershtein L, de Belder MA, Szwed H, Doerr R, Monti L, Alfakih K, Hochman JS, Maron DJ; ISCHEMIA Research Group. Outcomes With Intermediate Left Main Disease: Analysis From the ISCHEMIA Trial. Circ Cardiovasc Interv. 2022 Apr;15(4):e010925. doi: 10.1161/CIRCINTERVENTIONS.121.010925. Epub 2022 Apr 12.
Results Reference
derived
PubMed Identifier
35259918
Citation
Mark DB, Spertus JA, Bigelow R, Anderson S, Daniels MR, Anstrom KJ, Baloch KN, Cohen DJ, Held C, Goodman SG, Bangalore S, Cyr D, Reynolds HR, Alexander KP, Rosenberg Y, Stone GW, Maron DJ, Hochman JS; ISCHEMIA Research Group. Comprehensive Quality-of-Life Outcomes With Invasive Versus Conservative Management of Chronic Coronary Disease in ISCHEMIA. Circulation. 2022 Apr 26;145(17):1294-1307. doi: 10.1161/CIRCULATIONAHA.121.057363. Epub 2022 Mar 9.
Results Reference
derived
PubMed Identifier
35177194
Citation
Senior R, Reynolds HR, Min JK, Berman DS, Picard MH, Chaitman BR, Shaw LJ, Page CB, Govindan SC, Lopez-Sendon J, Peteiro J, Wander GS, Drozdz J, Marin-Neto J, Selvanayagam JB, Newman JD, Thuaire C, Christopher J, Jang JJ, Kwong RY, Bangalore S, Stone GW, O'Brien SM, Boden WE, Maron DJ, Hochman JS; ISCHEMIA Research Group. Predictors of Left Main Coronary Artery Disease in the ISCHEMIA Trial. J Am Coll Cardiol. 2022 Feb 22;79(7):651-661. doi: 10.1016/j.jacc.2021.11.052.
Results Reference
derived
PubMed Identifier
34521217
Citation
Newman JD, Anthopolos R, Mancini GBJ, Bangalore S, Reynolds HR, Kunichoff DF, Senior R, Peteiro J, Bhargava B, Garg P, Escobedo J, Doerr R, Mazurek T, Gonzalez-Juanatey J, Gajos G, Briguori C, Cheng H, Vertes A, Mahajan S, Guzman LA, Keltai M, Maggioni AP, Stone GW, Berger JS, Rosenberg YD, Boden WE, Chaitman BR, Fleg JL, Hochman JS, Maron DJ. Outcomes of Participants With Diabetes in the ISCHEMIA Trials. Circulation. 2021 Oct 26;144(17):1380-1395. doi: 10.1161/CIRCULATIONAHA.121.054439. Epub 2021 Sep 15.
Results Reference
derived
PubMed Identifier
34514494
Citation
Lopez-Sendon JL, Cyr DD, Mark DB, Bangalore S, Huang Z, White HD, Alexander KP, Li J, Nair RG, Demkow M, Peteiro J, Wander GS, Demchenko EA, Gamma R, Gadkari M, Poh KK, Nageh T, Stone PH, Keltai M, Sidhu M, Newman JD, Boden WE, Reynolds HR, Chaitman BR, Hochman JS, Maron DJ, O'Brien SM. Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial. Eur Heart J. 2022 Jan 13;43(2):148-149. doi: 10.1093/eurheartj/ehab509.
Results Reference
derived
PubMed Identifier
34496632
Citation
Reynolds HR, Shaw LJ, Min JK, Page CB, Berman DS, Chaitman BR, Picard MH, Kwong RY, O'Brien SM, Huang Z, Mark DB, Nath RK, Dwivedi SK, Smanio PEP, Stone PH, Held C, Keltai M, Bangalore S, Newman JD, Spertus JA, Stone GW, Maron DJ, Hochman JS. Outcomes in the ISCHEMIA Trial Based on Coronary Artery Disease and Ischemia Severity. Circulation. 2021 Sep 28;144(13):1024-1038. doi: 10.1161/CIRCULATIONAHA.120.049755. Epub 2021 Sep 9. Erratum In: Circulation. 2022 Jun 7;145(23):e1072. Circulation. 2022 Jul 5;146(1):e3.
Results Reference
derived
PubMed Identifier
33938917
Citation
White HD, O'Brien SM, Alexander KP, Boden WE, Bangalore S, Li J, Manjunath CN, Lopez-Sendon JL, Peteiro J, Gosselin G, Berger JS, Maggioni AP, Reynolds HR, Hochman JS, Maron DJ. Comparison of Days Alive Out of Hospital With Initial Invasive vs Conservative Management: A Prespecified Analysis of the ISCHEMIA Trial. JAMA Cardiol. 2021 Sep 1;6(9):1023-1031. doi: 10.1001/jamacardio.2021.1651.
Results Reference
derived
PubMed Identifier
33267610
Citation
Chaitman BR, Alexander KP, Cyr DD, Berger JS, Reynolds HR, Bangalore S, Boden WE, Lopes RD, Demkow M, Piero Perna G, Riezebos RK, McFalls EO, Banerjee S, Bagai A, Gosselin G, O'Brien SM, Rockhold FW, Waters DD, Thygesen KA, Stone GW, White HD, Maron DJ, Hochman JS; ISCHEMIA Research Group. Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons. Circulation. 2021 Feb 23;143(8):790-804. doi: 10.1161/CIRCULATIONAHA.120.047987. Epub 2020 Dec 3.
Results Reference
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PubMed Identifier
32862662
Citation
Lopes RD, Alexander KP, Stevens SR, Reynolds HR, Stone GW, Pina IL, Rockhold FW, Elghamaz A, Lopez-Sendon JL, Farsky PS, Chernyavskiy AM, Diaz A, Phaneuf D, De Belder MA, Ma YT, Guzman LA, Khouri M, Sionis A, Hausenloy DJ, Doerr R, Selvanayagam JB, Maggioni AP, Hochman JS, Maron DJ. Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial. Circulation. 2020 Nov 3;142(18):1725-1735. doi: 10.1161/CIRCULATIONAHA.120.050304. Epub 2020 Aug 29. Erratum In: Circulation. 2020 Oct 13;142(15):e236.
Results Reference
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PubMed Identifier
36277662
Citation
Gala ABE, Curzen N. Is There Still a Place for Revascularisation in the Management of Stable Coronary Artery Disease Following the ISCHEMIA Trial? Heart Int. 2020 Aug 8;14(1):13-15. doi: 10.17925/HI.2020.14.1.13. eCollection 2020.
Results Reference
derived
PubMed Identifier
32227755
Citation
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
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Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD, Mavromichalis S, Alexander KP, Cohen DJ, Bangalore S, Hochman JS, Mark DB; ISCHEMIA Research Group. Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1408-1419. doi: 10.1056/NEJMoa1916370. Epub 2020 Mar 30.
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Reynolds HR, Shaw LJ, Min JK, Spertus JA, Chaitman BR, Berman DS, Picard MH, Kwong RY, Bairey-Merz CN, Cyr DD, Lopes RD, Lopez-Sendon JL, Held C, Szwed H, Senior R, Gosselin G, Nair RG, Elghamaz A, Bockeria O, Chen J, Chernyavskiy AM, Bhargava B, Newman JD, Hinic SB, Jaroch J, Hoye A, Berger J, Boden WE, O'Brien SM, Maron DJ, Hochman JS; ISCHEMIA Research Group. Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):773-786. doi: 10.1001/jamacardio.2020.0822. Erratum In: JAMA Cardiol. 2021 Aug 1;6(8):980.
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Citation
Azevedo DFC, Lima EG, Ribeiro MOL, Linhares Filho JPP, Serrano Junior CV. Critical analysis of the classic indications for myocardial revascularization. Rev Assoc Med Bras (1992). 2019 Mar;65(3):319-325. doi: 10.1590/1806-9282.65.3.319. Epub 2019 Apr 11.
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PubMed Identifier
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Shaw LJ, Xie JX, Phillips LM, Goyal A, Reynolds HR, Berman DS, Picard MH, Bhargava B, Devlin G, Chaitman BR. Optimising diagnostic accuracy with the exercise ECG: opportunities for women and men with stable ischaemic heart disease. Heart Asia. 2016 Jun 1;8(2):1-7. doi: 10.1136/heartasia-2016-010736. eCollection 2016.
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PubMed Identifier
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Citation
Kataoka A, Scherrer-Crosbie M, Senior R, Gosselin G, Phaneuf D, Guzman G, Perna G, Lara A, Kedev S, Mortara A, El-Hajjar M, Shaw LJ, Reynolds HR, Picard MH. The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial. Cardiovasc Ultrasound. 2015 Dec 18;13:47. doi: 10.1186/s12947-015-0043-2.
Results Reference
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PubMed Identifier
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Citation
Stone GW, Hochman JS, Williams DO, Boden WE, Ferguson TB Jr, Harrington RA, Maron DJ. Medical Therapy With Versus Without Revascularization in Stable Patients With Moderate and Severe Ischemia: The Case for Community Equipoise. J Am Coll Cardiol. 2016 Jan 5;67(1):81-99. doi: 10.1016/j.jacc.2015.09.056. Epub 2015 Nov 23.
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Citation
Wasilewski J, Polonski L, Lekston A, Osadnik T, Regula R, Bujak K, Kurek A. Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center. Trials. 2015 Sep 15;16:411. doi: 10.1186/s13063-015-0934-4.
Results Reference
derived
Links:
URL
http://www.ischemiatrial.org/
Description
Main Website for ISCHEMIA Trial
URL
http://www.nlm.nih.gov/medlineplus/angioplasty.html
Description
Angioplasty
URL
http://www.nlm.nih.gov/medlineplus/coronaryarterybypasssurgery.html
Description
Coronary Artery Bypass Surgery
URL
http://www.nlm.nih.gov/medlineplus/coronaryarterydisease.html
Description
Coronary Artery Disease
URL
http://www.nlm.nih.gov/medlineplus/heartdiseases.html
Description
Heart Diseases
URL
https://doi.org/10.1016/j.ahj.2019.09.001
Description
ISCHEMIA Trial Update
Learn more about this trial
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
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