Cognitive Impairment, Coronary Artery Disease, Heart Failure
Conditions
Keywords
Coronary Artery Disease, Heart Failure, Ejection Fraction
Brief summary
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).
Interventions
Participants receive guideline-directed medical therapy (GDMT).
Participants receive coronary artery bypass grafting (CABG).
PROCEDUREPercutaneous coronary intervention (PCI).
Participants receive percutaneous coronary intervention (PCI).
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%) * Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography * CAD amenable to either PCI or CABG as determined by the local heart team * Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits * Participant is able and willing to give written informed consent
Exclusion criteria
* Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization * Concomitant significant valvular heart disease requiring surgery * Prior cardiac surgery * Dementia with loss of capacity to consent (clinically evident or previously diagnosed) * Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time * History of noncompliance with medical therapy * Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity * Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Cognitive Score | Month 12 | 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. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | Month 12 | 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. |
| Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF | Month 12 | Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability | Month 12 | Composite calculation of the number of participants with MCI, probable dementia or persistent disability in each arm. |
| Composite Number of: Death or Hospitalization for HF | Month 12 | Composite calculation of the number of participants who die or are hospitalized for HF in each arm. |
| Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause | Month 12 | Composite calculation of the number of participants who die or are hospitalized due to CV-related causes in each arm. |
| Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score | Month 12 | 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. |
| Self-Care of Heart Failure Index (SCHFI) | Month 12 | 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. |
Countries
Brazil, India, Mexico, Poland, South Korea, United States
Contacts
PRINCIPAL_INVESTIGATORS. Bangalore, MD
NYU Langone Health
Outcome results
None listed