Clinical trial NCT06399692: REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
Official title: REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: RECHARGE
Cardiac Surgery
coronary artery bypass grafting
percutaneous coronary intervention
Quality of Life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Icahn School of Medicine at Mount Sinai
First posted: 2024-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Female sex
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
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.)

Primary outcomes:
measure: Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
timeFrame: 5 years
Secondary outcomes:
measure: Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
timeFrame: 5 years
Other outcomes:
measure: Time-averaged changes in PROMIS-29 Scores
timeFrame: 1 month, 3months, 6months, 12months and annually after procedure
measure: Time-averaged changes in EQ5D-VAS Scores
timeFrame: 1 month, 3months, 6months, 12months and annually after procedure
measure: Time-averaged changes in PHQ Scores
timeFrame: 1 month, 3months, 6months, 12months and annually after procedure
measure: Time-averaged changes in MoCA scores
timeFrame: 1 month, 3months, 6months, 12months and annually after procedure
measure: Number of days alive and out of hospital after procedure
timeFrame: up to 5 years after procedure
measure: Time to death
timeFrame: 1 month after procedure
measure: Time to death
timeFrame: 3 months after procedure
measure: Time to death
timeFrame: 6 months after procedure
measure: Time to death
timeFrame: 12 months after procedure
measure: Time to death
timeFrame: 18 months after procedure
measure: Time to death
timeFrame: 24 months after procedure
measure: Time to death
timeFrame: 30 months after procedure
measure: Time to death
timeFrame: 36 months after procedure
measure: Time to death
timeFrame: 48 months after procedure
measure: Time to death
timeFrame: 60 months after procedure
measure: Time to death
timeFrame: 72 months after procedure
measure: Time to death
timeFrame: 84 months after procedure
measure: Time to death
timeFrame: 96 months after procedure
measure: Time to death
timeFrame: 108 months after procedure
measure: Time to death
timeFrame: 120 months after procedure
measure: Time to cardiovascular death
timeFrame: 1 month after procedure
measure: Time to cardiovascular death
timeFrame: 3 months after procedure
measure: Time to cardiovascular death
timeFrame: 6 months after procedure
measure: Time to cardiovascular death
timeFrame: 12 months after procedure
measure: Time to cardiovascular death
timeFrame: 18 months after procedure
measure: Time to cardiovascular death
timeFrame: 24 months after procedure
measure: Time to cardiovascular death
timeFrame: 30 months after procedure
measure: Time to cardiovascular death
timeFrame: 36 months after procedure
measure: Time to cardiovascular death
timeFrame: 48 months after procedure
measure: Time to cardiovascular death
timeFrame: 60 months after procedure
measure: Time to cardiovascular death
timeFrame: 72 months after procedure
measure: Time to cardiovascular death
timeFrame: 84 months after procedure
measure: Time to cardiovascular death
timeFrame: 96 months after procedure
measure: Time to cardiovascular death
timeFrame: 108 months after procedure
measure: Time to cardiovascular death
timeFrame: 120 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 1 month after procedure
measure: Time to non-cardiovascular death
timeFrame: 3 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 6 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 12 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 18 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 24 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 30 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 36 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 48 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 60 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 72 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 84 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 96 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 108 months after procedure
measure: Time to non-cardiovascular death
timeFrame: 120 months after procedure
measure: Time to myocardial infarction
timeFrame: 1 month after procedure
measure: Time to myocardial infarction
timeFrame: 3 months after procedure
measure: Time to myocardial infarction
timeFrame: 6 months after procedure
measure: Time to myocardial infarction
timeFrame: 12 months after procedure
measure: Time to myocardial infarction
timeFrame: 18 months after procedure
measure: Time to myocardial infarction
timeFrame: 24 months after procedure
measure: Time to myocardial infarction
timeFrame: 30 months after procedure
measure: Time to myocardial infarction
timeFrame: 36 months after procedure
measure: Time to myocardial infarction
timeFrame: 48 months after procedure
measure: Time to myocardial infarction
timeFrame: 60 months after procedure
measure: Time to myocardial infarction
timeFrame: 72 months after procedure
measure: Time to myocardial infarction
timeFrame: 84 months after procedure
measure: Time to myocardial infarction
timeFrame: 96 months after procedure
measure: Time to myocardial infarction
timeFrame: 108 months after procedure
measure: Time to myocardial infarction
timeFrame: 120 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 1 month after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 3 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 6 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 12 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 18 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 24 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 30 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 36 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 48 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 60 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 72 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 84 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 96 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 108 months after procedure
measure: Time to stroke/transient ischemic attack
timeFrame: 120 months after procedure
measure: Time to hospitalization
timeFrame: 1 month after procedure
measure: Time to hospitalization
timeFrame: 3 months after procedure
measure: Time to hospitalization
timeFrame: 6 months after procedure
measure: Time to hospitalization
timeFrame: 12 months after procedure
measure: Time to hospitalization
timeFrame: 18 months after procedure
measure: Time to hospitalization
timeFrame: 24 months after procedure
measure: Time to hospitalization
timeFrame: 30 months after procedure
measure: Time to hospitalization
timeFrame: 36 months after procedure
measure: Time to hospitalization
timeFrame: 48 months after procedure
measure: Time to hospitalization
timeFrame: 60 months after procedure
measure: Time to hospitalization
timeFrame: 72 months after procedure
measure: Time to hospitalization
timeFrame: 84 months after procedure
measure: Time to hospitalization
timeFrame: 96 months after procedure
measure: Time to hospitalization
timeFrame: 108 months after procedure
measure: Time to hospitalization
timeFrame: 120 months after procedure
measure: Time to unplanned revascularization
timeFrame: 1 month after procedure
measure: Time to unplanned revascularization
timeFrame: 3 months after procedure
measure: Time to unplanned revascularization
timeFrame: 6 months after procedure
measure: Time to unplanned revascularization
timeFrame: 12 months after procedure
measure: Time to unplanned revascularization
timeFrame: 18 months after procedure
measure: Time to unplanned revascularization
timeFrame: 24 months after procedure
measure: Time to unplanned revascularization
timeFrame: 30 months after procedure
measure: Time to unplanned revascularization
timeFrame: 36 months after procedure
measure: Time to unplanned revascularization
timeFrame: 48 months after procedure
measure: Time to unplanned revascularization
timeFrame: 60 months after procedure
measure: Time to unplanned revascularization
timeFrame: 72 months after procedure
measure: Time to unplanned revascularization
timeFrame: 84 months after procedure
measure: Time to unplanned revascularization
timeFrame: 96 months after procedure
measure: Time to unplanned revascularization
timeFrame: 108 months after procedure
measure: Time to unplanned revascularization
timeFrame: 120 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 1 month after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 3 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 6 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 12 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 18 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 24 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 30 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 36 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 48 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 60 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 72 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 84 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 96 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 108 months after procedure
measure: Time to atrial fibrillation/ atrial flutter
timeFrame: 120 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 1 month after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 3 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 6 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 12 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 18 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 24 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 30 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 36 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 48 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 60 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 72 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 84 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 96 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 108 months after procedure
measure: Time to ventricular tachycardia/ventricular fibrillation
timeFrame: 120 months after procedure
measure: Time to heart block
timeFrame: 1 month after procedure
measure: Time to heart block
timeFrame: 3 months after procedure
measure: Time to heart block
timeFrame: 6 months after procedure
measure: Time to heart block
timeFrame: 12 months after procedure
measure: Time to heart block
timeFrame: 18 months after procedure
measure: Time to heart block
timeFrame: 24 months after procedure
measure: Time to heart block
timeFrame: 30 months after procedure
measure: Time to heart block
timeFrame: 36 months after procedure
measure: Time to heart block
timeFrame: 48 months after procedure
measure: Time to heart block
timeFrame: 60 months after procedure
measure: Time to heart block
timeFrame: 72 months after procedure
measure: Time to heart block
timeFrame: 84 months after procedure
measure: Time to heart block
timeFrame: 96 months after procedure
measure: Time to heart block
timeFrame: 108 months after procedure
measure: Time to heart block
timeFrame: 120 months after procedure
measure: Time to bleeding
timeFrame: 1 month after procedure
measure: Time to bleeding
timeFrame: 3 months after procedure
measure: Time to bleeding
timeFrame: 6 months after procedure
measure: Time to bleeding
timeFrame: 12 months after procedure
measure: Time to bleeding
timeFrame: 18 months after procedure
measure: Time to bleeding
timeFrame: 24 months after procedure
measure: Time to bleeding
timeFrame: 30 months after procedure
measure: Time to bleeding
timeFrame: 36 months after procedure
measure: Time to bleeding
timeFrame: 48 months after procedure
measure: Time to bleeding
timeFrame: 60 months after procedure
measure: Time to bleeding
timeFrame: 72 months after procedure
measure: Time to bleeding
timeFrame: 84 months after procedure
measure: Time to bleeding
timeFrame: 96 months after procedure
measure: Time to bleeding
timeFrame: 108 months after procedure
measure: Time to bleeding
timeFrame: 120 months after procedure
measure: Time to vascular complications
timeFrame: 1 month after procedure
measure: Time to vascular complications
timeFrame: 3 months after procedure
measure: Time to vascular complications
timeFrame: 6 months after procedure
measure: Time to vascular complications
timeFrame: 12 months after procedure
measure: Time to vascular complications
timeFrame: 18 months after procedure
measure: Time to vascular complications
timeFrame: 24 months after procedure
measure: Time to vascular complications
timeFrame: 30 months after procedure
measure: Time to vascular complications
timeFrame: 36 months after procedure
measure: Time to vascular complications
timeFrame: 48 months after procedure
measure: Time to vascular complications
timeFrame: 60 months after procedure
measure: Time to vascular complications
timeFrame: 72 months after procedure
measure: Time to vascular complications
timeFrame: 84 months after procedure
measure: Time to vascular complications
timeFrame: 96 months after procedure
measure: Time to vascular complications
timeFrame: 108 months after procedure
measure: Time to vascular complications
timeFrame: 120 months after procedure
measure: Time to heart failure
timeFrame: 1 month after procedure
measure: Time to heart failure
timeFrame: 3 months after procedure
measure: Time to heart failure
timeFrame: 6 months after procedure
measure: Time to heart failure
timeFrame: 12 months after procedure
measure: Time to heart failure
timeFrame: 18 months after procedure
measure: Time to heart failure
timeFrame: 24 months after procedure
measure: Time to heart failure
timeFrame: 30 months after procedure
measure: Time to heart failure
timeFrame: 36 months after procedure
measure: Time to heart failure
timeFrame: 48 months after procedure
measure: Time to heart failure
timeFrame: 60 months after procedure
measure: Time to heart failure
timeFrame: 72 months after procedure
measure: Time to heart failure
timeFrame: 84 months after procedure
measure: Time to heart failure
timeFrame: 96 months after procedure
measure: Time to heart failure
timeFrame: 108 months after procedure
measure: Time to heart failure
timeFrame: 120 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 1 month after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 3 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 6 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 12 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 18 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 24 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 30 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 36 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 48 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 60 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 72 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 84 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 96 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 108 months after procedure
measure: Time to left ventricular assist device/orthotopic heart transplant
timeFrame: 120 months after procedure
measure: Time to infection
timeFrame: 1 month after procedure
measure: Time to infection
timeFrame: 3 months after procedure
measure: Time to infection
timeFrame: 6 months after procedure
measure: Time to infection
timeFrame: 12 months after procedure
measure: Time to infection
timeFrame: 18 months after procedure
measure: Time to infection
timeFrame: 24 months after procedure
measure: Time to infection
timeFrame: 30 months after procedure
measure: Time to infection
timeFrame: 36 months after procedure
measure: Time to infection
timeFrame: 48 months after procedure
measure: Time to infection
timeFrame: 60 months after procedure
measure: Time to infection
timeFrame: 72 months after procedure
measure: Time to infection
timeFrame: 84 months after procedure
measure: Time to infection
timeFrame: 96 months after procedure
measure: Time to infection
timeFrame: 108 months after procedure
measure: Time to infection
timeFrame: 120 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 1 month after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 3 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 6 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 12 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 18 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 24 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 30 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 36 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 48 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 60 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 72 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 84 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 96 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 108 months after procedure
measure: Time to acute kidney injury/chronic kidney disease
timeFrame: 120 months after procedure
measure: Number of subjects with complete revascularization
timeFrame: 30 days after procedure
measure: Number of subjects with reasonably complete revascularization
timeFrame: 30 days after procedure
measure: Change in blood lipids
timeFrame: Baseline, 12 months post-procedure
measure: Change in hemoglobin
timeFrame: Baseline, 12 months post-procedure
measure: Change in LVEF
timeFrame: Baseline, 12 months post-procedure
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Carmel
country: United States
facility: Ascension St. Vincent Cardiovascular Research Institute
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
city: Flushing
country: United States
facility: NewYork-Presbyterian Hospital - Queens
state: New York
city: New York
country: United States
facility: Icahn School of Medicine - Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: Icahn School of Medicine - Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine / NYPH
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Memphis
country: United States
facility: Methodist Le Bonheur Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Ascension Saint Thomas Hospital
state: Tennessee
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Gregg S Stone, MD, FACC, MSCAI
role: PRINCIPAL_INVESTIGATOR
References: