Cardiac MRI to find tissue damage and predict outcomes after coronary revascularization
STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)
This study will test whether heart MRI scans can help predict which adults with reduced heart pumping function and multivessel coronary disease are more likely to have heart failure, readmission, or death after planned stent or bypass procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 9 sites (Brooklyn, New York and 8 other locations) |
| Trial ID | NCT07133984 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with LVEF ≤ 40% and multivessel coronary artery disease or left main disease who are scheduled for PCI or CABG within three months are ideal candidates.
Not a fit: People with contraindications to MRI, those without significant multivessel or left main coronary disease, or those not planning revascularization are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the imaging approach could identify patients at higher risk after revascularization so clinicians can tailor treatment plans and follow-up intensity.
How similar studies have performed: Prior multicenter viability studies using mixed imaging modalities produced negative results, but newer cardiac MRI techniques and single-center data suggest LGE, ischemia, and non-ischemic substrate may predict remodeling and outcomes, so the approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Planned CABG or PCI within 3 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. \-
Where this trial is running
Brooklyn, New York and 8 other locations
- 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)
- Sunnybrook Health Sciences Centre — Toronto, Canada (Recruiting)
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
- Dedinje Cardiovascular Institute — Belgrade, Serbia (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.