NCT06399692

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a research study in women 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: Women 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Coronary artery bypass grafting (CABG)	Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
PROCEDURE	Percutaneous coronary intervention (PCI)	Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart

Timeline

• Start date: 2024-09-16
• Primary completion: 2033-03-15
• Completion: 2039-01-01
• First posted: 2024-05-06
• Last updated: 2025-10-01

Locations

18 sites across 1 country: United States