REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
Weill Medical College of Cornell University
Summary
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.
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must identify as a minority 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: 1. 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 PC…
Interventions
- ProcedureCoronary artery bypass grafting
Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
- ProcedurePercutaneous coronary intervention
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart
Locations (18)
- Adventist Health GlendaleGlendale, California
- Emory UniversityAtlanta, Georgia
- Ascension St. Vincent Cardiovascular Research InstituteCarmel, Indiana
- Baptist Health LexingtonLexington, Kentucky
- Baptist Health LouisvilleLouisville, Kentucky
- Massachusetts General HospitalBoston, Massachusetts