International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial (ISCHEMIA-LVD)

NYU Langone Health

Status and phase: Begins enrollment in 9 months; Phase 3

Conditions: Coronary Artery Disease; Cognitive Impairment; Heart Failure

Treatments: Procedure: Guideline-directed medical therapy (GDMT); Procedure: Percutaneous coronary intervention (PCI).; Procedure: Coronary artery bypass grafting (CABG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06566183

Pending

Details and patient eligibility

About

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).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 3 patient groups

GDMT

Experimental group

Description:

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT.

Treatment:

Procedure: Guideline-directed medical therapy (GDMT)

CABG

Experimental group

Description:

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG.

Treatment:

Procedure: Coronary artery bypass grafting (CABG)

PCI

Experimental group

Description:

Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI.

Treatment:

Procedure: Percutaneous coronary intervention (PCI).