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Study temporarily paused.
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The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDMT | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT. |
|
| CABG | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG. |
|
| PCI | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guideline-directed medical therapy (GDMT) | Procedure | Participants receive guideline-directed medical therapy (GDMT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Cognitive Score | A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB. | Month 12 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. | Month 12 |
| Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF | Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability | Composite calculation of the number of participants with MCI, probable dementia or persistent disability in each arm. | Month 12 |
| Composite Number of: Death or Hospitalization for HF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. Bangalore, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States | ||
| International Study Site |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sripal.bangalore@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Sripal.bangalore@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Coronary artery bypass grafting (CABG) | Procedure | Participants receive coronary artery bypass grafting (CABG). |
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| Percutaneous coronary intervention (PCI). | Procedure | Participants receive percutaneous coronary intervention (PCI). |
|
Composite calculation of the number of participants who die or are hospitalized for HF in each arm. |
| Month 12 |
| Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause | Composite calculation of the number of participants who die or are hospitalized due to CV-related causes in each arm. | Month 12 |
| Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score | The SAQ Physical Limitations and Quality of Life domain comprises 2 items of the SAQ corresponding with angina-related physical limitations and quality of life (QOL). The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges where: 0 to 24 represents poor health status, 25 to 49 represents fair status, 50 to 74 represents good status, and 75 to 100 represents excellent status. | Month 12 |
| Self-Care of Heart Failure Index (SCHFI) | The SCHFI is a 39-item questionnaire assessing HF patients' performance of self-care activities related to HF, including how often they complete self-care, how likely they are to perform certain activities, and how confident they feel in performing the activities. Each item is rated on a scale from 1-5; the total score is the sum of responses and ranges from 39-195. Higher scores indicate greater overall performance of self-care activities related to HF. | Month 12 |
| International Study Site |
| Brazil |
| International Study Site | International Study Site | India |
| International Study Site | International Study Site | Mexico |
| International Study Site | International Study Site | Poland |
| International Study Site | International Study Site | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060825 | Cognitive Dysfunction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D057510 | Endovascular Procedures |
| D019060 | Minimally Invasive Surgical Procedures |
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