Comparing two methods for heart revascularization in patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with multivessel coronary artery disease and left ventricular dysfunction. Patients will be randomly assigned to receive either PCI with drug-eluting stents or CABG, with both groups receiving optimal medical therapy for heart failure. The study aims to determine which revascularization strategy provides better outcomes for patients suffering from ischemic cardiomyopathy. Follow-up assessments will occur at multiple intervals over three years to monitor patient health and recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram
* Multivessel disease suitable for revascularization:

  * Three vessel disease
  * Two vessel disease involving left main or proximal left anterior descending artery
* Clinical and anatomic eligibility for both percutaneous coronary intervention (PCI) and Coronary artery bypass grafting (CABG) as agreed to by the local Heart Team (interventionalist determines PCI appropriateness and eligibility; cardiac surgeon determines surgical appropriateness and eligibility)
* Ability to sign informed consent and comply with all study procedures, including follow-up for at least two years
* Affiliation to health insurance

Exclusion Criteria:

* Prior:

  * PCI of any coronary artery lesions within 6 months prior to randomization
  * CABG at any time prior to randomization
* Ongoing cardiogenic shock at the time of coronary angiogram (SBP\< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
* Contra indication for PCI or CABG determined by the heart team
* Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed
* ST elevation myocardial infarction \< 30 days
* Non-cardiac illness with a life expectancy of less than 24 months
* Current participation in other investigational drug or device studies
* Women who are pregnant or nursing
* Females of childbearing potential without effective method of birth control
* Patients who are under tutorship or curatorship
* Patient on AME (state medical aid)

Where it's running

• Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
  Créteil, Val De Marne, France Recruiting

Study contacts

• Principal investigator: Romain GALLET, MD, PhD — Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
• Study coordinator: Romain GALLET, MD, PhD
• Email: romain.gallet@aphp.fr
• Phone: 149812111 (Ext: 36771)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.