Clinical trial NCT06566183: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
Official title: ISCHEMIA-LVD: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Cognitive Impairment
Heart Failure
Keywords: Coronary Artery Disease
Heart Failure
Ejection Fraction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Composite Cognitive Score
timeFrame: Month 12
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
timeFrame: Month 12
measure: Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF
timeFrame: Month 12
Secondary outcomes:
measure: Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability
timeFrame: Month 12
measure: Composite Number of: Death or Hospitalization for HF
timeFrame: Month 12
measure: Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause
timeFrame: Month 12
measure: Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score
timeFrame: Month 12
measure: Self-Care of Heart Failure Index (SCHFI)
timeFrame: Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: International Study Site
country: Brazil
facility: International Study Site
city: International Study Site
country: India
facility: International Study Site
city: International Study Site
country: Korea, Republic of
facility: International Study Site
city: International Study Site
country: Mexico
facility: International Study Site
city: International Study Site
country: Poland
facility: International Study Site
Study officials:
affiliation: NYU Langone Health
name: S. Bangalore, MD
role: PRINCIPAL_INVESTIGATOR
References: