REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities (NCT06399705) | Clinical Trial Compass
RecruitingPhase 3
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
United States600 participantsStarted 2024-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must identify as a minority
✓. Patient is at least 18 years old.
✓. 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.
✓. 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
✕. Cardiogenic shock
✕. Prior PCI within 1 year or any prior CABG anytime
✕. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
✕. Planned single vessel revascularization (other than isolated left main disease)
✕. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
What they're measuring
1
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
Timeframe: 5 years
Trial details
NCT IDNCT06399705
SponsorWeill Medical College of Cornell University
✕. 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 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 Current participation in another investigational drug or device study that has not reached its primary endpoint Life-expectancy less than 3 years due to concomitant non-cardiac conditions 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.)