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

Part of paid clinical trials in Glendale, California.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06399692
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Coronary artery bypass grafting (CABG) — PROCEDURE
    Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
  • Percutaneous coronary intervention (PCI) — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
Sep 16, 2024
Status verified
Sep 2025
Primary completion
Mar 15, 2033
Completion
Jan 1, 2039

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: RECHARGE:Women - CABG
  • Other: RECHARGE:Women - PCI

Primary Outcome Measure

Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2 [ Time Frame: 5 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Adventist Health GlendaleGlendaleCalifornia91206-
Emory UniversityAtlantaGeorgia30322-
Ascension St. Vincent Cardiovascular Research InstituteCarmelIndiana46290-
Baptist Health LexingtonLexingtonKentucky40503-
Baptist Health LouisvilleLouisvilleKentucky40207-
Massachusetts General HospitalBostonMassachusetts02114-
Englewood HospitalEnglewoodNew Jersey07631-
NewYork-Presbyterian Hospital - QueensFlushingNew York11355-
Columbia University Irving Medical Center/NewYork-Presbyterian HospitalNew YorkNew York10032-
Icahn School of Medicine - Mount Sinai HospitalNew YorkNew York10029-
Icahn School of Medicine - Mount Sinai MorningsideNew YorkNew York10025-
Weill Cornell Medicine / NYPHNew YorkNew York10065-
Westchester Medical CenterValhallaNew York10595-
Duke UniversityDurhamNorth Carolina27710-
Ohio State UniversityColumbusOhio43210-
Methodist Le Bonheur HealthcareMemphisTennessee38104-
Ascension Saint Thomas HospitalNashvilleTennessee37205-
Baylor Scott and WhiteDallasTexas75246-

Find similar trials in Glendale, CA

By research site
Adventist Health Glendale· Glendale, CAEmory University· Atlanta, GAAscension St. Vincent Cardiovascular Research Institute· Carmel, INBaptist Health Lexington· Lexington, KYBaptist Health Louisville· Louisville, KYMassachusetts General Hospital· Boston, MA

Related Studies