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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial (DTU-STEMI)

Primary Purpose

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Impella CP® placement prior to reperfusion with Primary PCI
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation (STEMI) Myocardial Infarction of Anterior Wall focused on measuring Anterior STEMI, ST-Elevated MI, Cardiac Unloading

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-80 years
  2. First myocardial infarction
  3. Acute anterior STEMI with ≥2 mm in 2 or more contiguous anterior leads or ≥ 4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
  4. Patient presents to the hospital between 1 - 5 hours of ischemic pain onset
  5. Patient indicated for Primary PCI
  6. Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent

Exclusion Criteria:

  1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
  2. Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any impairment in mental status, cognition, or any global or focal neurological deficit
  3. Administration of fibrinolytic therapy within 24 hours prior to enrollment
  4. Cardiogenic shock defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion or use of IABP or any other circulatory support device
  5. Inferior STEMI or suspected right ventricular failure
  6. Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
  7. Severe aortic stenosis
  8. Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
  9. Suspected or known pregnancy
  10. Suspected systemic active infection
  11. History or known hepatic insufficiency prior to catheterization
  12. On renal replacement therapy
  13. COPD with home oxygen therapy or on chronic steroid therapy
  14. Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
  15. Prior CABG or LAD PCI
  16. History of heart failure
  17. Prior aortic valve surgery or TAVR
  18. Left bundle branch block (new or old)
  19. History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
  20. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
  21. Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)

    Known contraindication to:

  22. Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia]
  23. Heparin, pork, pork products or contrast media
  24. Receiving a drug-eluting stent
  25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint.
  26. Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the study.
  27. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs.
  28. Subject belongs to a vulnerable population [Vulnerable patient populations are defined as Individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention].

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • HonorHealth Research InstituteRecruiting
  • The University of ArizonaRecruiting
  • Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
  • Cedars-Sinai Medical Center
  • Riverside Community HospitalRecruiting
  • St. Anthony HospitalRecruiting
  • Hartford Health CareRecruiting
  • Christiana Care Health ServicesRecruiting
  • George Washington UniversityRecruiting
  • BayCare Cardiology - Morton Plant HospitalRecruiting
  • Baptist Health Research InstituteRecruiting
  • Tallahasse Research InstituteRecruiting
  • AdventHealth - TampaRecruiting
  • Northside Hospital
  • University Health, Inc
  • Wellstar/Kennestone Hospital
  • North Shore University Health SystemRecruiting
  • Midwest Cardiovascular Institute
  • Advocate Edward Hospital
  • Southern Illinois University School of Medicine
  • Mercy Iowa HeartRecruiting
  • Tufts Medical CenterRecruiting
  • Mass General Hospital
  • Henry Ford HospitalRecruiting
  • Ascension St. John Hospital
  • SpectrumRecruiting
  • Metropolitan Heart and Vascular Institue
  • Concord Hospital
  • Hackensack Medical CenterRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • New Mexico Heart InstituteRecruiting
  • Presbyterian Heart Research GroupRecruiting
  • University of Buffalo HospitalRecruiting
  • Northwell HealthRecruiting
  • NYU School of MedicineRecruiting
  • Stony Brook Medicine
  • University Hospitals Cleveland Medical CenterRecruiting
  • Kettering Medical CenterRecruiting
  • Oklahoma Heart InstituteRecruiting
  • UPMC HamotRecruiting
  • Allegheny General Hospital
  • UPMC PresbyterianRecruiting
  • Prisma HealthRecruiting
  • Greenville Health SystemRecruiting
  • Ballad Health - Wellmont CVA InstituteRecruiting
  • University of Tennessee Medical CenterRecruiting
  • Centennial Medical Center
  • The University of Texas Health Science Center at HoustonRecruiting
  • Methodist HospitalRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Providence Regional Medical Center - Everett
  • Charleston Area Medical Center
  • West Virginia University Hospital
  • University Hospital WürzburgRecruiting
  • Stadtische Kliniken Neuss- LukaskrankenhausRecruiting
  • University Hospital DüsseldorfRecruiting
  • West German Heart Center EssenRecruiting
  • Krankenhaus der Barmherzigen Brüder TrierRecruiting
  • Heart Center DresdenRecruiting
  • University Hospital of MarburgRecruiting
  • Heinrich-Braun-Klinikum ZwickauRecruiting
  • Ospedale Policlinico San Martino
  • San RaffaeleRecruiting
  • Azienda Ospedaliera Universitaria Integrata Di Verona
  • ASST Grande Ospedale Metropolitano Niguarda
  • Humanitas Clinical & Research Hospital
  • Erasmus MC RotterdamRecruiting
  • Bern University Hospital
  • Luzerner KantonsspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Outcomes

Primary Outcome Measures

Infarct Size
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging

Secondary Outcome Measures

Infarct Size, as a percent of Left Ventricular Mass
Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Impella CP® related Major Bleeding and Major Vascular complications
Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals.
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.

Full Information

First Posted
May 6, 2019
Last Updated
July 18, 2023
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03947619
Brief Title
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Acronym
DTU-STEMI
Official Title
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
October 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
Detailed Description
To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Keywords
Anterior STEMI, ST-Elevated MI, Cardiac Unloading

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design
Masking
Outcomes Assessor
Masking Description
Blinding of the operator and patient is not possible given the nature of the treatment.
Allocation
Randomized
Enrollment
668 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
Intervention Type
Device
Intervention Name(s)
Impella CP® placement prior to reperfusion with Primary PCI
Intervention Description
Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
Primary Outcome Measure Information:
Title
Infarct Size
Description
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
Time Frame
3-5 days post-procedure
Secondary Outcome Measure Information:
Title
Infarct Size, as a percent of Left Ventricular Mass
Description
Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Time Frame
3-5 days
Title
Impella CP® related Major Bleeding and Major Vascular complications
Description
Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals.
Time Frame
30 Days
Title
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
Description
Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-85 years First myocardial infarction Acute anterior STEMI with ≥2 mm in 2 or more contiguous anterior leads or ≥ 4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram Patient presents to the hospital between 1 - 6 hours of ischemic pain onset Patient indicated for Primary PCI Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent Exclusion Criteria: Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization) Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition, or any global or focal neurological deficit Administration of fibrinolytic therapy within 24 hours prior to enrollment Cardiogenic shock defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion or use of IABP or any other circulatory support device Inferior STEMI or suspected right ventricular failure Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses Severe aortic stenosis Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation Suspected or known pregnancy Suspected systemic active infection History or known hepatic insufficiency prior to catheterization On renal replacement therapy COPD with home oxygen therapy or on chronic steroid therapy Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads Prior CABG or LAD PCI History of heart failure (documented history of EF <40% or documented hospitalization for HF within one (1) year prior to screening) Prior aortic valve surgery or TAVR Left bundle branch block (new or old) History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin) Known contraindication to: Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia] Heparin, pork, pork products or contrast media Receiving a drug-eluting stent Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint. Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the study. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs. Subject belongs to a vulnerable population [Vulnerable patient populations are defined as Individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention].
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Poornima Sood, MD, MBA
Phone
978-882-8494
Email
psood@abiomed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Wood, RN
Email
dwood@abiomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navin Kapur, MD
Organizational Affiliation
Tufts University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William O'Neill, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Vines
First Name & Middle Initial & Last Name & Degree
Samuel McElwee, MD
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
82258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Vanderhoof
First Name & Middle Initial & Last Name & Degree
David Rizik, MD
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saul Garcia
First Name & Middle Initial & Last Name & Degree
Arka Chatterjee, MD
Facility Name
Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Toven
First Name & Middle Initial & Last Name & Degree
Sami Hayek, MD
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Withdrawn
Facility Name
Riverside Community Hospital
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Mathews
First Name & Middle Initial & Last Name & Degree
Patrick Hu, MD
Facility Name
St. Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bailey
Email
dbailey@chvpc.com
First Name & Middle Initial & Last Name & Degree
Nima Aghili, MD
Facility Name
Hartford Health Care
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Cloutier
Email
jill.cloutier@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Asad Rizvi, MD
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Moore
First Name & Middle Initial & Last Name & Degree
Neil Wimmer, MD
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Smith
Email
sarsmith@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Ramesh Mazhari, MD
Facility Name
BayCare Cardiology - Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wathey
First Name & Middle Initial & Last Name & Degree
Lang Lin, MD
Facility Name
Baptist Health Research Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doran Cassidy
Phone
904-202-7218
Email
doran.cassidy@bmcax.com
First Name & Middle Initial & Last Name & Degree
Siddharth Wayangankar, MD
Facility Name
Tallahasse Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Playsay
Phone
304-376-5267
Email
repla@southern-med.com
First Name & Middle Initial & Last Name & Degree
Pablo N Rengifo, MD
Facility Name
AdventHealth - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Bala
First Name & Middle Initial & Last Name & Degree
Oliver Abela, MD
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Ferreira
First Name & Middle Initial & Last Name & Degree
Cindy Grines, MD
Facility Name
University Health, Inc
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Individual Site Status
Withdrawn
Facility Name
Wellstar/Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Pierchala
First Name & Middle Initial & Last Name & Degree
Justin Levisay, MD
Facility Name
Midwest Cardiovascular Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Benoit
First Name & Middle Initial & Last Name & Degree
Mark Goodwin, MD
Facility Name
Advocate Edward Hospital
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Individual Site Status
Withdrawn
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Milbrandt, MD
First Name & Middle Initial & Last Name & Degree
Abdul Hafiz, MD
Facility Name
Mercy Iowa Heart
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra McCombs
First Name & Middle Initial & Last Name & Degree
Mark Tannenbaum, MD
First Name & Middle Initial & Last Name & Degree
David McAllister, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilma Castaneda
Phone
617-636-7537
First Name & Middle Initial & Last Name & Degree
Carey Kimmelstiel, MD
Facility Name
Mass General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Withdrawn
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Fox, RN
Phone
313-916-1879
Email
mfox2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Gerald Koenig, MD
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Spectrum
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Vanoosterhout
Phone
616-160-9380
First Name & Middle Initial & Last Name & Degree
David Wohns, MD
Facility Name
Metropolitan Heart and Vascular Institue
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Individual Site Status
Withdrawn
Facility Name
Concord Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Rocheford
First Name & Middle Initial & Last Name & Degree
Patrick Magnus, MD
Facility Name
Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Canino
First Name & Middle Initial & Last Name & Degree
Haroon Faraz, MD
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DeToro
First Name & Middle Initial & Last Name & Degree
Aditya Mehra, MD
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Atondo
First Name & Middle Initial & Last Name & Degree
Ramzan Zakir, MD
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Garcia
Email
deanna.garcia@lovelace.com
First Name & Middle Initial & Last Name & Degree
Jennifer Cordova
Email
jennifer.cordova@lovelace.com
First Name & Middle Initial & Last Name & Degree
Mark Bieniarz, MD
Facility Name
Presbyterian Heart Research Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebany Martinez-Finley
First Name & Middle Initial & Last Name & Degree
Adam Banks, MD
Facility Name
University of Buffalo Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Steinig
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Dalangin
Email
IDalangin@northwell.edu
First Name & Middle Initial & Last Name & Degree
Perwaiz Meraj, MD
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Ann Rodriguez
Email
crystalann.rodriguez@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Louai Razzouk, MD
Facility Name
Stony Brook Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11789
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy McKnight, RN
Email
amy.mcknight@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Paul Poommipanit, MD
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Connolly
First Name & Middle Initial & Last Name & Degree
Raja Nazir, MD
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Brooks
First Name & Middle Initial & Last Name & Degree
Wayne Leimbach, MD
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Henry
First Name & Middle Initial & Last Name & Degree
Becky Thiele
First Name & Middle Initial & Last Name & Degree
Timothy Trageser, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Withdrawn
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Carbone
Email
lamarcab@upmc.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Fowler, MD
Facility Name
Prisma Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Buchanan
First Name & Middle Initial & Last Name & Degree
Patrick Hall, MD
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Bentley
First Name & Middle Initial & Last Name & Degree
David Manly, MD
Facility Name
Ballad Health - Wellmont CVA Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terrie Walker
First Name & Middle Initial & Last Name & Degree
Chris Metzger, MD
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandy Herbert
First Name & Middle Initial & Last Name & Degree
Raj Baljepally, MD
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Guerro
First Name & Middle Initial & Last Name & Degree
Sachin Kumar, MD
First Name & Middle Initial & Last Name & Degree
Marwan Jumean, MD
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Carreon
First Name & Middle Initial & Last Name & Degree
Nandish Thukral, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelle Zulick
First Name & Middle Initial & Last Name & Degree
Deepak Talreja, MD
Facility Name
Providence Regional Medical Center - Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Individual Site Status
Withdrawn
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa Buravezky
First Name & Middle Initial & Last Name & Degree
PD Dr. Peter Nordbeck
Facility Name
Stadtische Kliniken Neuss- Lukaskrankenhaus
City
Neuss
State/Province
North Rhine-Westphalia
ZIP/Postal Code
41464
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Bienefeld
First Name & Middle Initial & Last Name & Degree
Prof. Michael Haude
Facility Name
University Hospital Düsseldorf
City
Dusseldorf
State/Province
NRW
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santina Zirpoli
First Name & Middle Initial & Last Name & Degree
PD Dr. Ralf Westenfeld
Facility Name
West German Heart Center Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Dumin
First Name & Middle Initial & Last Name & Degree
Dr. Fadi Al-Rashid
Facility Name
Krankenhaus der Barmherzigen Brüder Trier
City
Trier
State/Province
RP
ZIP/Postal Code
54290
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silke Plattfaut
First Name & Middle Initial & Last Name & Degree
PD Dr. Nikos Werner
Facility Name
Heart Center Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Famulla
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Norman Mangner
Facility Name
University Hospital of Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Birgit Markus
First Name & Middle Initial & Last Name & Degree
Dr. Birgit Markus
Facility Name
Heinrich-Braun-Klinikum Zwickau
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christin Von Müller, MD
Phone
0375 51-55500
Email
Christin.Mueller@HBK-Zwickau.de
First Name & Middle Initial & Last Name & Degree
Heike Kolpack, RN
Email
heike.kolpack@hbk-zwickau.de
First Name & Middle Initial & Last Name & Degree
Holger Sigusch, MD
Facility Name
Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Matteo Toma
First Name & Middle Initial & Last Name & Degree
Prof. Italo Porto
Facility Name
San Raffaele
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vega Rusconi
First Name & Middle Initial & Last Name & Degree
Dr. Alaide Chieffo
Facility Name
Azienda Ospedaliera Universitaria Integrata Di Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Pesarini
First Name & Middle Initial & Last Name & Degree
Dr. Flavio Ribichini
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Dario Brunelli
First Name & Middle Initial & Last Name & Degree
Jacopo Andrea Oreglia, MD
Facility Name
Humanitas Clinical & Research Hospital
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Letizia Bertoldi
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
Facility Name
Erasmus MC Rotterdam
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Huijskens-Van Herpen
First Name & Middle Initial & Last Name & Degree
Prof. Nicolas Van Mieghem
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Luzerner Kantonsspital
City
Lucerne
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitta Mehmann
First Name & Middle Initial & Last Name & Degree
PD Dr. Florim Cuculi

12. IPD Sharing Statement

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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

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