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Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac CT
Invasive Coronary Angiography
Sponsored by
MDDX LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Cardiac CT, Catheterization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  1. Age >18 years
  2. Patients providing written informed consent
  3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

EXCLUSION CRITERIA

  1. Known CAD (myocardial infarction, PCI, CABG)
  2. ACC/AHA Class I or III indication for ICA
  3. Non-cardiac illness with life expectancy <2 years
  4. Inability to provide written informed consent
  5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  6. Pregnant women
  7. Allergy to iodinated contrast agent
  8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
  9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
  10. Heart rate ≥100 beats per minute

12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Sites / Locations

  • Walter Reed Medical Center
  • Quanta Diagnostico Nuclear, Curitiba-PR
  • FACTS
  • Centro Cardiologico Monzino
  • Kangwon National University Hospital
  • Ajou University Hospital
  • Gangnam Severance Hospital
  • Gangneung Asan Hospital
  • Korea university, Guro hospital
  • Pusan National University Hospital
  • Severance Hospital
  • Yeongnam University Hospital
  • Institute of Cardiology Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cardiac CT

Invasive Coronary Angiography

Arm Description

Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)

Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography

Outcomes

Primary Outcome Measures

MACE Endpoints
Death Non-fatal myocardial infarction Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) Stroke Urgent or emergent coronary revascularization Cardiovascular hospitalization (including for angina, heart failure or other)

Secondary Outcome Measures

Additional MACE Endpoints
The primary composite MACE endpoint plus major bleeding. The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage. The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.

Full Information

First Posted
February 22, 2013
Last Updated
March 21, 2017
Sponsor
MDDX LLC
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01810198
Brief Title
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Acronym
CONSERVE
Official Title
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MDDX LLC
Collaborators
GE Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.
Detailed Description
A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Cardiac CT, Catheterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac CT
Arm Type
Active Comparator
Arm Description
Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
Arm Title
Invasive Coronary Angiography
Arm Type
Active Comparator
Arm Description
Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography
Intervention Type
Procedure
Intervention Name(s)
Cardiac CT
Intervention Description
Perform a non-invasive Cardiac CT Angiogram
Intervention Type
Procedure
Intervention Name(s)
Invasive Coronary Angiography
Intervention Description
Patient undergoes Invasive Coronary Angiography
Primary Outcome Measure Information:
Title
MACE Endpoints
Description
Death Non-fatal myocardial infarction Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) Stroke Urgent or emergent coronary revascularization Cardiovascular hospitalization (including for angina, heart failure or other)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Additional MACE Endpoints
Description
The primary composite MACE endpoint plus major bleeding. The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage. The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Economic
Description
The secondary economic endpoint is within-trial cardiovascular costs*. *Costs will include index- and downstream CAD-related costs related to diagnostic testing, medications, hospitalizations, emergency department visits, outpatient visits, and coronary revascularizations. (Costs will also include non-CAD-related but test related costs.)
Time Frame
1 year
Title
Secondary Safety Endpoint
Description
The secondary safety endpoint will be rates of serious test-related complications*. *Serious test-related complications will include contrast-induced nephropathy, hematoma requiring transfusion, arteriovenous fistula, aneurysm formation, retroperitoneal bleed, arterial dissection and any surgery for test-related complications and cumulative CAD test-related effective biological radiation dose.
Time Frame
1 year
Title
Quality of Life
Description
The tertiary endpoint will be general and angina-specific quality of life, as measured by the EQ-5D Health Survey and Seattle Angina Questionnaire, respectively.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Age >18 years Patients providing written informed consent Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication EXCLUSION CRITERIA Known CAD (myocardial infarction, PCI, CABG) ACC/AHA Class I or III indication for ICA Non-cardiac illness with life expectancy <2 years Inability to provide written informed consent Concomitant participation in another clinical trial in which subject is subject to investigational drug or device Pregnant women Allergy to iodinated contrast agent Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.) Heart rate ≥100 beats per minute 12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Min, MD
Organizational Affiliation
Cornell Weill Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Gebow, PhD
Organizational Affiliation
MDDX LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyuk-Jae Chang, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Medical Center
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Quanta Diagnostico Nuclear, Curitiba-PR
City
Curitiba
Country
Brazil
Facility Name
FACTS
City
Hyderabad
Country
India
Facility Name
Centro Cardiologico Monzino
City
Monzino
Country
Italy
Facility Name
Kangwon National University Hospital
City
Seoul
State/Province
South Korea
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea university, Guro hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeongnam University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Institute of Cardiology Warsaw
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30553687
Citation
Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.
Results Reference
derived

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Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

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