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

Phase 3

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary artery bypass grafting; Procedure: Percutaneous coronary intervention

• Registration Number: NCT06399705
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed 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 transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-06
• Status Verified: 2024-10
• Study Start: 2024-10-02
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-04
• Primary Completion: 2033-03-15
• Study Completion: 2039-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECHARGE: Minorities - CABG	Coronary artery bypass grafting	-
RECHARGE: Minorities - PCI	Percutaneous coronary intervention	-

Primary Outcome Measures

Name	Time	Method
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2	5 years	Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio will be used

Secondary Outcome Measures

Name	Time	Method
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS	5 years	Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.

Trial Locations

Locations (14)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Ascension St. Vincent Cardiovascular Research Institute; 🇺🇸 Carmel, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Englewood Hospital; 🇺🇸 Englewood, New Jersey, United States

NewYork-Presbyterian Hospital - Queens; 🇺🇸 Flushing, New York, United States

Icahn School of Medicine - Mount Sinai Morningside; 🇺🇸 New York, New York, United States

Icahn School of Medicine - Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital; 🇺🇸 New York, New York, United States

Weill Cornell Medicine/NewYork-Presbyterian Hospital; 🇺🇸 New York, New York, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Methodist Le Bonheur Healthcare; 🇺🇸 Memphis, Tennessee, United States

Ascension Saint Thomas Hospital; 🇺🇸 Nashville, Tennessee, United States