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
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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NOT_YET_RECRUITING
PHASE3
1200 participants
INTERVENTIONAL
2026-12-31
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Guideline-directed medical therapy (GDMT)
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.
Coronary artery bypass grafting (CABG)
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.
Percutaneous coronary intervention (PCI).
Participants receive percutaneous coronary intervention (PCI).
Interventions
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Guideline-directed medical therapy (GDMT)
Participants receive guideline-directed medical therapy (GDMT).
Coronary artery bypass grafting (CABG)
Participants receive coronary artery bypass grafting (CABG).
Percutaneous coronary intervention (PCI).
Participants receive percutaneous coronary intervention (PCI).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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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
International Study Site
International Study Site, , Brazil
International Study Site
International Study Site, , India
International Study Site
International Study Site, , Mexico
International Study Site
International Study Site, , Poland
International Study Site
International Study Site, , South Korea
Countries
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Central Contacts
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Other Identifiers
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Pending
Identifier Type: -
Identifier Source: org_study_id
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