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

NCT ID: NCT06566183

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2032-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Artery Disease Cognitive Impairment Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GDMT

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

Group Type EXPERIMENTAL

Guideline-directed medical therapy (GDMT)

Intervention Type PROCEDURE

Participants receive guideline-directed medical therapy (GDMT).

CABG

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

Group Type EXPERIMENTAL

Coronary artery bypass grafting (CABG)

Intervention Type PROCEDURE

Participants receive coronary artery bypass grafting (CABG).

PCI

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

Group Type EXPERIMENTAL

Percutaneous coronary intervention (PCI).

Intervention Type PROCEDURE

Participants receive percutaneous coronary intervention (PCI).

Interventions

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Guideline-directed medical therapy (GDMT)

Participants receive guideline-directed medical therapy (GDMT).

Intervention Type PROCEDURE

Coronary artery bypass grafting (CABG)

Participants receive coronary artery bypass grafting (CABG).

Intervention Type PROCEDURE

Percutaneous coronary intervention (PCI).

Participants receive percutaneous coronary intervention (PCI).

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Bangalore, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

International Study Site

International Study Site, , Brazil

Site Status

International Study Site

International Study Site, , India

Site Status

International Study Site

International Study Site, , Mexico

Site Status

International Study Site

International Study Site, , Poland

Site Status

International Study Site

International Study Site, , South Korea

Site Status

Countries

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United States Brazil India Mexico Poland South Korea

Central Contacts

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S. Bangalore, MD

Role: CONTACT

212-263-5656

Other Identifiers

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Pending

Identifier Type: -

Identifier Source: org_study_id

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