Cardiac MRI to find tissue damage and predict outcomes after coronary revascularization

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 is a prospective observational study enrolling adults with ischemic left ventricular systolic dysfunction (LVEF ≤ 40%) and prognostically important multivessel or left main coronary disease who plan to undergo PCI or CABG within three months. Participants will undergo multiparametric cardiac magnetic resonance imaging including late gadolinium enhancement and dark-blood LGE to quantify infarct transmurality, hypoperfusion (jeopardized viable myocardium), and non-ischemic substrate. Imaging findings will be related to postoperative adverse cardiovascular events such as heart failure, readmission, and death. The goal is to determine whether these CMR markers identify mechanisms of remodeling and predict differential outcomes after revascularization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women ≥ 18 years old
2. LVEF ≤ 40% (quantified by echo, single-photon emission computed tomography \[SPECT\], or CMR within 2 months of enrollment)
3. Prognostically important CAD: either multivessel CAD (triple vessel or double vessel CAD including left anterior descendant artery (LAD), significant coronary stenosis defined as ≥ 70% based on coronary angiography, fractional flow reserve (FFR) ≤ 0.80 or instantaneous wave-free ratio (iFR) ≤ 0.89) or left main disease (+/- other CAD) for which significant stenosis defined as \> 50% based on coronary angiography, intravascular ultrasound (IVUS) minimum luminal area \[MLA\] value ≤ 6.0 mm2 (\< 4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements.
4. Either planned CABG/PCI within 3 months or CABG/PCI within the last 9 months.

Exclusion Criteria:

1. Concomitant valve disease or other condition (e.g., LV aneurysm) requiring surgical repair or replacement
2. Contraindication to CMR (i.e. magnetically activated materials), gadolinium, regadenoson/adenosine/dipyridamole
3. Active neoplasm and/or severe end-organ dysfunction with expected life expectancy less than 5 years.

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Where it's running

• NewYork-Presbyterian Brooklyn Methodist Hospital
  Brooklyn, New York, United States Recruiting
• New York Presbyterian - Queens
  Flushing, New York, United States Recruiting
• Weill Cornell Medicine/NewYork Presbyterian Hospital
  New York, New York, United States Recruiting
• MU Vienna Austria
  Vienna, Austria Recruiting
• Libin Cardiovascular Institute
  Calgary, Alberta, Canada Recruiting
• Universite Laval Quebec (CRIUCPQ) Canada
  Québec, Canada Recruiting

Study contacts

• Principal investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC — Weill Medical College of Cornell University
• Study coordinator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
• Email: sticos@med.cornell.edu
• Phone: 212.746.1812

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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.