REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Apr 30, 2024

Keywords

ClinConnect Summary

The RECHARGE Trial is a research study aimed at understanding which of two heart procedures is better for people from minority backgrounds with coronary artery disease (CAD). The study compares two methods that help restore blood flow to the heart: one is a minimally invasive procedure where doctors use a balloon and a small mesh tube to open blocked arteries, often done through a small cut in the wrist or groin. The other is an open-heart surgery that uses healthy blood vessels from another part of the body to create a new path for blood, bypassing the blocked areas. The researchers will look at how well each method works in terms of survival and improving quality of life for patients.

To participate in this trial, individuals need to identify as a minority, be at least 18 years old, and have a specific type of heart disease that requires one of these procedures. Participants will need to agree to follow-up appointments and complete quality-of-life questionnaires. The trial is currently recruiting participants, so if you or a loved one meet the criteria, it could be a great opportunity to contribute to important research while receiving care for heart health.

Gender

ALL

Eligibility criteria

• 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 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
• • 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 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.)