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

Launched by NYU LANGONE HEALTH · Aug 20, 2024

Keywords

ClinConnect Summary

The ISCHEMIA-HF trial is a research study designed to compare different treatment approaches for patients with heart failure caused by coronary artery disease (CAD). Specifically, it will look at how effective guideline-directed medical therapy (GDMT), coronary artery bypass grafting (CABG), and percutaneous coronary intervention (PCI) are for individuals who have a weakened heart (with an ejection fraction of 40% or less) and significant blockages in their heart arteries. The goal is to find out which treatment works best for improving heart health and overall quality of life.

To be eligible for this trial, participants must have a recent measurement showing their heart's pumping ability is low (40% or less), and they must be diagnosed with severe blockages in multiple heart arteries. They also need to be open to following the treatment plan and attending follow-up visits. However, people with certain conditions, such as recent heart failure episodes, major valve issues needing surgery, or those who have had previous heart surgery, will not be able to participate. The trial is currently not recruiting participants, but it aims to gather valuable information to help improve heart treatments in the future.

Gender

ALL

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)