NCT06566183

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).

Trial Health

70
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
73mo left

Started Dec 2026

Longer than P75 for phase_3 coronary-artery-disease

Geographic Reach
6 countries

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

August 20, 2024

Last Update Submit

July 2, 2025

Conditions

Coronary Artery DiseaseCognitive ImpairmentHeart Failure

Keywords

Coronary Artery DiseaseHeart FailureEjection Fraction

Outcome Measures

Primary Outcomes (3)

  • Composite Cognitive Score

    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.

    Month 12

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) Score

    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.

    Month 12

  • Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF

    Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm.

    Month 12

Secondary Outcomes (5)

  • Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability

    Month 12

  • Composite Number of: Death or Hospitalization for HF

    Month 12

  • Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause

    Month 12

  • Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score

    Month 12

  • Self-Care of Heart Failure Index (SCHFI)

    Month 12

Study Arms (3)

GDMT

EXPERIMENTAL

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

Procedure: Guideline-directed medical therapy (GDMT)

CABG

EXPERIMENTAL

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

Procedure: Coronary artery bypass grafting (CABG)

PCI

EXPERIMENTAL

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

Procedure: Percutaneous coronary intervention (PCI).

Interventions

Guideline-directed medical therapy (GDMT)PROCEDURE

Participants receive guideline-directed medical therapy (GDMT).

GDMT
Coronary artery bypass grafting (CABG)PROCEDURE

Participants receive coronary artery bypass grafting (CABG).

CABG
Percutaneous coronary intervention (PCI).PROCEDURE

Participants receive percutaneous coronary intervention (PCI).

PCI

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

NYU Langone Health

New York, New York, 10016, United States

Location

International Study Site

International Study Site, Brazil

Location

International Study Site

International Study Site, India

Location

International Study Site

International Study Site, Mexico

Location

International Study Site

International Study Site, Poland

Location

International Study Site

International Study Site, South Korea

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCognitive DysfunctionHeart Failure

Interventions

Coronary Artery BypassPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical ProceduresEndovascular ProceduresMinimally Invasive Surgical Procedures

Study Officials

  • S. Bangalore, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

S. Bangalore, MD

CONTACT

212-263-5656Sripal.bangalore@nyulangone.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2032

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sripal.bangalore@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Sripal.bangalore@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ME(1)KR(1)IN(1)BR(1)US(1)PL(1)