Coronary Artery Disease
Conditions
Keywords
RECHARGE, Cardiac Surgery, Minority, percutaneous coronary intervention, Quality of Life
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.
Interventions
PROCEDURECoronary artery bypass grafting
Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
PROCEDUREPercutaneous coronary intervention
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
Sponsors
Weill Medical College of Cornell University
Patient-Centered Outcomes Research Institute
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The researchers and most study personnel (including those from the QOL follow-up center and events assessors, clinical events committee and angiographic core laboratory) will be blinded to allocated treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must identify as Black race or Hispanic ethnicity 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, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure 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 8. 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 9. Current participation in another investigational drug or device study that has not reached its primary endpoint 10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions 11. 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
CONTACTGregg Stone, MD, FACC, MSCAI
PRINCIPAL_INVESTIGATORMario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORGregg Stone, MD, FACC, MSCAI
Icahn School of Medicine at Mount Sinai
Outcome results
None listed