Comparing heart procedures for minorities with coronary artery disease

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

This study is testing which heart procedure, either bypass surgery or a less invasive method, works better for minority patients with coronary artery disease to improve their health and quality of life.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Weill Medical College of Cornell University (other)
• Locations: 18 sites (Glendale, California and 17 other locations)
• Trial ID: NCT06399705 on ClinicalTrials.gov

What this trial studies

The RECHARGE Trial focuses on evaluating the outcomes of two different heart procedures—coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)—specifically in minority populations. This multicenter, randomized trial will assess survival rates and quality of life improvements over a follow-up period of up to 10 years. Participants will be monitored through regular follow-ups and health assessments to determine the effectiveness of each procedure. The study aims to provide valuable insights into the best treatment options for under-represented groups suffering from coronary artery disease.

Who should consider this trial

Good fit: Ideal candidates for this study are minority patients aged 18 and older with multivessel or left main coronary artery disease who are eligible for either CABG or PCI.

Not a fit: Patients with recent heart attacks, cardiogenic shock, or those requiring other cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved treatment strategies and outcomes for minority patients with coronary artery disease.

How similar studies have performed: Other studies have shown success in evaluating treatment options for coronary artery disease, but this specific focus on minority populations is relatively novel.

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.)

Where this trial is running

Glendale, California and 17 other locations

• Adventist Health Glendale — Glendale, California, United States (RECRUITING)
• Emory University — Atlanta, Georgia, United States (RECRUITING)
• Ascension St. Vincent Cardiovascular Research Institute — Carmel, Indiana, United States (RECRUITING)
• Baptist Health Lexington — Lexington, Kentucky, United States (RECRUITING)
• Baptist Health Louisville — Louisville, Kentucky, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• Englewood Hospital — Englewood, New Jersey, United States (RECRUITING)
• NewYork-Presbyterian Hospital - Queens — Flushing, New York, United States (RECRUITING)
• Icahn School of Medicine - Mount Sinai Morningside — New York, New York, United States (RECRUITING)
• Icahn School of Medicine - Mount Sinai Hospital — New York, New York, United States (RECRUITING)
• Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)
• Weill Cornell Medicine/NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)
• Westchester Medical Center — Valhalla, New York, United States (RECRUITING)
• Duke University — Durham, North Carolina, United States (RECRUITING)
• Ohio State University — Columbus, Ohio, United States (RECRUITING)
• Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (RECRUITING)
• Ascension Saint Thomas Hospital — Nashville, Tennessee, United States (RECRUITING)
• Baylor Scott and White — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC — Weill Medical College of Cornell University
• Study coordinator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

Conditions: Coronary Artery Disease, RECHARGE, Cardiac Surgery, Minority, percutaneous coronary intervention, Quality of Life