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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
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) 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
Adventist Health Glendale
Glendale, California, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGAscension St. Vincent Cardiovascular Research Institute
Carmel, Indiana, United States
RECRUITINGBaptist Health Lexington
Lexington, Kentucky, United States
RECRUITINGBaptist Health Louisville
Louisville, Kentucky, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGEnglewood Hospital
Englewood, New Jersey, United States
RECRUITINGNewYork-Presbyterian Hospital - Queens
Flushing, New York, United States
RECRUITINGIcahn School of Medicine - Mount Sinai Morningside
New York, New York, United States
RECRUITINGIcahn School of Medicine - Mount Sinai Hospital
New York, New York, United States
RECRUITING...and 8 more locations
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
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 method will be utilized
Time frame: 5 years
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
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.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.