REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
Trial ID or NCT#
Status
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.
Official Title
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
Eligibility Criteria
- 1. Patient must identify as Black race or Hispanic ethnicity2. 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.
- 1. ST-segment elevation MI within 3 days2. Cardiogenic shock3. Prior PCI within 1 year or any prior CABG anytime4. 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 procedure7. 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 randomization8. 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 syndrome9. Current participation in another investigational drug or device study that has not reached its primary endpoint10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions11. 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.)
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Gregg.Stone@mountsinai.org
View on ClinicalTrials.gov
