REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
Purpose
This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.
Condition
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient must identify as Black race or Hispanic ethnicity 2. Patient is at least 18 years old. 3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment. 4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
Exclusion Criteria
- ST-segment elevation MI within 3 days 2. Cardiogenic shock 3. Prior PCI within 1 year or any prior CABG anytime 4. Planned hybrid revascularization (PCI after CABG or CABG after PCI) 5. Planned single vessel revascularization (other than isolated left main disease) 6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure 7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization 8. Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome 9. Current participation in another investigational drug or device study that has not reached its primary endpoint 10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions 11. Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The researchers and most study personnel (including those from the QOL follow-up center and events assessors, clinical events committee and angiographic core laboratory) will be blinded to allocated treatment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other RECHARGE: Minorities - CABG |
|
|
|
Other RECHARGE: Minorities - PCI |
|
Recruiting Locations
Glendale, California 91206
Atlanta, Georgia 30322
Carmel, Indiana 46290
Lexington, Kentucky 40503
Louisville, Kentucky 40207
Boston, Massachusetts 02114
Englewood, New Jersey 07631
Flushing, New York 11355
New York, New York 10025
New York, New York 10029
New York, New York 10032
New York, New York 10065
Valhalla, New York 10595
Durham, North Carolina 27710
Columbus, Ohio 43210
Memphis, Tennessee 38104
Nashville, Tennessee 37205
Dallas, Texas 75246
More Details
- Status
- Recruiting
- Sponsor
- Weill Medical College of Cornell University
Study Contact
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACCGregg.Stone@mountsinai.org
mfg9004@med.cornell.edu
Detailed Description
The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial. Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.