Coronary Artery Disease Clinical Trial
— RECHARGE:WOfficial title:
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
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.
| Status | Not yet recruiting |
| Enrollment | 600 |
| Est. completion date | January 1, 2039 |
| Est. primary completion date | March 15, 2033 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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.) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Weill Cornell Medicine / NYP | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Weill Medical College of Cornell University | Icahn School of Medicine at Mount Sinai, Patient-Centered Outcomes Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time-averaged changes in PROMIS-29 Scores | The PROMIS-29 instrument measures pain intensity on a scale of 0-10 plus 7 health domains: pain interference, fatigue, sleep disturbance, depressive symptoms, anxiety, physical function, and ability to participate in social roles. Each of the 7 domains is scored separately, with the lowest score for an individual domain being 4 and the highest being 20. Pain intensity is scored on the scale from 1-10. A mean of 50 and a standard deviation of 10 represent the general US population. A T-score rescales the raw scores to standardized scores. For most measures, higher T-scores indicate more of the concept being measured, except for physical function, which is reverse-scored (lower scores indicate worse function). | 1 month, 3months, 6months, 12months and annually after procedure | |
| Other | Time-averaged changes in EQ5D-VAS Scores | The EQ5D-VAS records self-rated health status on a graduated visual analog scale (VAS) from 0-100, with higher scores for higher health-related quality of life. It also includes the EQ-5D descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | 1 month, 3months, 6months, 12months and annually after procedure | |
| Other | Time-averaged changes in PHQ Scores | The Patient Health Questionnaire (PHQ-8) is an 8-item questionnaire used to diagnose and quantify the severity of depressive symptoms. It is designed to evaluate the overall QOL of the individual and questions are based on the diagnostic criteria for Major Depressive Disorder outlined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5). The lowest score is 0 and the highest score is 24. Scores =10 suggest a substantial burden of depressive symptoms. | 1 month, 3months, 6months, 12months and annually after procedure | |
| Other | Time-averaged changes in MoCA scores | The telephone Montreal Cognitive Assessment (MoCA Blind or T-MoCA) is a tool to assess mild cognitive impairment. The MoCA BlindT-MoCA consists of 15 non-visual items that assesses different cognitive domains, including attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The maximum score is 22 points with a score of 18 or below signifying mild cognitive dysfunction. | 1 month, 3months, 6months, 12months and annually after procedure | |
| Other | Number of days alive and out of hospital after procedure | up to 5 years after procedure | ||
| Other | Time to death | 1 month after procedure | ||
| Other | Time to death | 3 months after procedure | ||
| Other | Time to death | 6 months after procedure | ||
| Other | Time to death | 12 months after procedure | ||
| Other | Time to death | 18 months after procedure | ||
| Other | Time to death | 24 months after procedure | ||
| Other | Time to death | 30 months after procedure | ||
| Other | Time to death | 36 months after procedure | ||
| Other | Time to death | 48 months after procedure | ||
| Other | Time to death | 60 months after procedure | ||
| Other | Time to death | 72 months after procedure | ||
| Other | Time to death | 84 months after procedure | ||
| Other | Time to death | 96 months after procedure | ||
| Other | Time to death | 108 months after procedure | ||
| Other | Time to death | 120 months after procedure | ||
| Other | Time to cardiovascular death | 1 month after procedure | ||
| Other | Time to cardiovascular death | 3 months after procedure | ||
| Other | Time to cardiovascular death | 6 months after procedure | ||
| Other | Time to cardiovascular death | 12 months after procedure | ||
| Other | Time to cardiovascular death | 18 months after procedure | ||
| Other | Time to cardiovascular death | 24 months after procedure | ||
| Other | Time to cardiovascular death | 30 months after procedure | ||
| Other | Time to cardiovascular death | 36 months after procedure | ||
| Other | Time to cardiovascular death | 48 months after procedure | ||
| Other | Time to cardiovascular death | 60 months after procedure | ||
| Other | Time to cardiovascular death | 72 months after procedure | ||
| Other | Time to cardiovascular death | 84 months after procedure | ||
| Other | Time to cardiovascular death | 96 months after procedure | ||
| Other | Time to cardiovascular death | 108 months after procedure | ||
| Other | Time to cardiovascular death | 120 months after procedure | ||
| Other | Time to non-cardiovascular death | 1 month after procedure | ||
| Other | Time to non-cardiovascular death | 3 months after procedure | ||
| Other | Time to non-cardiovascular death | 6 months after procedure | ||
| Other | Time to non-cardiovascular death | 12 months after procedure | ||
| Other | Time to non-cardiovascular death | 18 months after procedure | ||
| Other | Time to non-cardiovascular death | 24 months after procedure | ||
| Other | Time to non-cardiovascular death | 30 months after procedure | ||
| Other | Time to non-cardiovascular death | 36 months after procedure | ||
| Other | Time to non-cardiovascular death | 48 months after procedure | ||
| Other | Time to non-cardiovascular death | 60 months after procedure | ||
| Other | Time to non-cardiovascular death | 72 months after procedure | ||
| Other | Time to non-cardiovascular death | 84 months after procedure | ||
| Other | Time to non-cardiovascular death | 96 months after procedure | ||
| Other | Time to non-cardiovascular death | 108 months after procedure | ||
| Other | Time to non-cardiovascular death | 120 months after procedure | ||
| Other | Time to myocardial infarction | 1 month after procedure | ||
| Other | Time to myocardial infarction | 3 months after procedure | ||
| Other | Time to myocardial infarction | 6 months after procedure | ||
| Other | Time to myocardial infarction | 12 months after procedure | ||
| Other | Time to myocardial infarction | 18 months after procedure | ||
| Other | Time to myocardial infarction | 24 months after procedure | ||
| Other | Time to myocardial infarction | 30 months after procedure | ||
| Other | Time to myocardial infarction | 36 months after procedure | ||
| Other | Time to myocardial infarction | 48 months after procedure | ||
| Other | Time to myocardial infarction | 60 months after procedure | ||
| Other | Time to myocardial infarction | 72 months after procedure | ||
| Other | Time to myocardial infarction | 84 months after procedure | ||
| Other | Time to myocardial infarction | 96 months after procedure | ||
| Other | Time to myocardial infarction | 108 months after procedure | ||
| Other | Time to myocardial infarction | 120 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 1 month after procedure | ||
| Other | Time to stroke/transient ischemic attack | 3 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 6 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 12 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 18 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 24 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 30 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 36 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 48 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 60 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 72 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 84 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 96 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 108 months after procedure | ||
| Other | Time to stroke/transient ischemic attack | 120 months after procedure | ||
| Other | Time to hospitalization | 1 month after procedure | ||
| Other | Time to hospitalization | 3 months after procedure | ||
| Other | Time to hospitalization | 6 months after procedure | ||
| Other | Time to hospitalization | 12 months after procedure | ||
| Other | Time to hospitalization | 18 months after procedure | ||
| Other | Time to hospitalization | 24 months after procedure | ||
| Other | Time to hospitalization | 30 months after procedure | ||
| Other | Time to hospitalization | 36 months after procedure | ||
| Other | Time to hospitalization | 48 months after procedure | ||
| Other | Time to hospitalization | 60 months after procedure | ||
| Other | Time to hospitalization | 72 months after procedure | ||
| Other | Time to hospitalization | 84 months after procedure | ||
| Other | Time to hospitalization | 96 months after procedure | ||
| Other | Time to hospitalization | 108 months after procedure | ||
| Other | Time to hospitalization | 120 months after procedure | ||
| Other | Time to unplanned revascularization | 1 month after procedure | ||
| Other | Time to unplanned revascularization | 3 months after procedure | ||
| Other | Time to unplanned revascularization | 6 months after procedure | ||
| Other | Time to unplanned revascularization | 12 months after procedure | ||
| Other | Time to unplanned revascularization | 18 months after procedure | ||
| Other | Time to unplanned revascularization | 24 months after procedure | ||
| Other | Time to unplanned revascularization | 30 months after procedure | ||
| Other | Time to unplanned revascularization | 36 months after procedure | ||
| Other | Time to unplanned revascularization | 48 months after procedure | ||
| Other | Time to unplanned revascularization | 60 months after procedure | ||
| Other | Time to unplanned revascularization | 72 months after procedure | ||
| Other | Time to unplanned revascularization | 84 months after procedure | ||
| Other | Time to unplanned revascularization | 96 months after procedure | ||
| Other | Time to unplanned revascularization | 108 months after procedure | ||
| Other | Time to unplanned revascularization | 120 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 1 month after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 3 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 6 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 12 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 18 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 24 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 30 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 36 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 48 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 60 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 72 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 84 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 96 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 108 months after procedure | ||
| Other | Time to atrial fibrillation/ atrial flutter | 120 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 1 month after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 3 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 6 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 12 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 18 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 24 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 30 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 36 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 48 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 60 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 72 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 84 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 96 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 108 months after procedure | ||
| Other | Time to ventricular tachycardia/ventricular fibrillation | 120 months after procedure | ||
| Other | Time to heart block | 1 month after procedure | ||
| Other | Time to heart block | 3 months after procedure | ||
| Other | Time to heart block | 6 months after procedure | ||
| Other | Time to heart block | 12 months after procedure | ||
| Other | Time to heart block | 18 months after procedure | ||
| Other | Time to heart block | 24 months after procedure | ||
| Other | Time to heart block | 30 months after procedure | ||
| Other | Time to heart block | 36 months after procedure | ||
| Other | Time to heart block | 48 months after procedure | ||
| Other | Time to heart block | 60 months after procedure | ||
| Other | Time to heart block | 72 months after procedure | ||
| Other | Time to heart block | 84 months after procedure | ||
| Other | Time to heart block | 96 months after procedure | ||
| Other | Time to heart block | 108 months after procedure | ||
| Other | Time to heart block | 120 months after procedure | ||
| Other | Time to bleeding | 1 month after procedure | ||
| Other | Time to bleeding | 3 months after procedure | ||
| Other | Time to bleeding | 6 months after procedure | ||
| Other | Time to bleeding | 12 months after procedure | ||
| Other | Time to bleeding | 18 months after procedure | ||
| Other | Time to bleeding | 24 months after procedure | ||
| Other | Time to bleeding | 30 months after procedure | ||
| Other | Time to bleeding | 36 months after procedure | ||
| Other | Time to bleeding | 48 months after procedure | ||
| Other | Time to bleeding | 60 months after procedure | ||
| Other | Time to bleeding | 72 months after procedure | ||
| Other | Time to bleeding | 84 months after procedure | ||
| Other | Time to bleeding | 96 months after procedure | ||
| Other | Time to bleeding | 108 months after procedure | ||
| Other | Time to bleeding | 120 months after procedure | ||
| Other | Time to vascular complications | 1 month after procedure | ||
| Other | Time to vascular complications | 3 months after procedure | ||
| Other | Time to vascular complications | 6 months after procedure | ||
| Other | Time to vascular complications | 12 months after procedure | ||
| Other | Time to vascular complications | 18 months after procedure | ||
| Other | Time to vascular complications | 24 months after procedure | ||
| Other | Time to vascular complications | 30 months after procedure | ||
| Other | Time to vascular complications | 36 months after procedure | ||
| Other | Time to vascular complications | 48 months after procedure | ||
| Other | Time to vascular complications | 60 months after procedure | ||
| Other | Time to vascular complications | 72 months after procedure | ||
| Other | Time to vascular complications | 84 months after procedure | ||
| Other | Time to vascular complications | 96 months after procedure | ||
| Other | Time to vascular complications | 108 months after procedure | ||
| Other | Time to vascular complications | 120 months after procedure | ||
| Other | Time to heart failure | 1 month after procedure | ||
| Other | Time to heart failure | 3 months after procedure | ||
| Other | Time to heart failure | 6 months after procedure | ||
| Other | Time to heart failure | 12 months after procedure | ||
| Other | Time to heart failure | 18 months after procedure | ||
| Other | Time to heart failure | 24 months after procedure | ||
| Other | Time to heart failure | 30 months after procedure | ||
| Other | Time to heart failure | 36 months after procedure | ||
| Other | Time to heart failure | 48 months after procedure | ||
| Other | Time to heart failure | 60 months after procedure | ||
| Other | Time to heart failure | 72 months after procedure | ||
| Other | Time to heart failure | 84 months after procedure | ||
| Other | Time to heart failure | 96 months after procedure | ||
| Other | Time to heart failure | 108 months after procedure | ||
| Other | Time to heart failure | 120 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 1 month after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 3 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 6 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 12 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 18 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 24 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 30 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 36 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 48 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 60 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 72 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 84 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 96 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 108 months after procedure | ||
| Other | Time to left ventricular assist device/orthotopic heart transplant | 120 months after procedure | ||
| Other | Time to infection | 1 month after procedure | ||
| Other | Time to infection | 3 months after procedure | ||
| Other | Time to infection | 6 months after procedure | ||
| Other | Time to infection | 12 months after procedure | ||
| Other | Time to infection | 18 months after procedure | ||
| Other | Time to infection | 24 months after procedure | ||
| Other | Time to infection | 30 months after procedure | ||
| Other | Time to infection | 36 months after procedure | ||
| Other | Time to infection | 48 months after procedure | ||
| Other | Time to infection | 60 months after procedure | ||
| Other | Time to infection | 72 months after procedure | ||
| Other | Time to infection | 84 months after procedure | ||
| Other | Time to infection | 96 months after procedure | ||
| Other | Time to infection | 108 months after procedure | ||
| Other | Time to infection | 120 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 1 month after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 3 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 6 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 12 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 18 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 24 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 30 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 36 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 48 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 60 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 72 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 84 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 96 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 108 months after procedure | ||
| Other | Time to acute kidney injury/chronic kidney disease | 120 months after procedure | ||
| Other | Number of subjects with complete revascularization | 30 days after procedure | ||
| Other | Number of subjects with reasonably complete revascularization | 30 days after procedure | ||
| Other | Change in blood lipids | Baseline, 12 months post-procedure | ||
| Other | Change in hemoglobin | Baseline, 12 months post-procedure | ||
| Other | Change in LVEF | Measured change in hemoglobin from baseline to 12 months post-procedure | Baseline, 12 months post-procedure | |
| Primary | 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 | 5 years | |
| Secondary | 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. | 5 years |
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