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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Participants receive guideline-directed medical therapy (GDMT).
Participants receive coronary artery bypass grafting (CABG).
Participants receive percutaneous coronary intervention (PCI).
NYU Langone Health
New York, New York, United States
International Study Site
International Study Site, Brazil
International Study Site
International Study Site, India
International Study Site
International Study Site, Mexico
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
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.
Time frame: Month 12
Composite Number of: Death or Hospitalization for HF
Composite calculation of the number of participants who die or are hospitalized for HF in each arm.
Time frame: 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.
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International Study Site
International Study Site, Poland
International Study Site
International Study Site, South Korea
Time frame: 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.
Time frame: 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.
Time frame: Month 12