Back to Trials
NCT07133984Recruiting

STICH3C Cardiac Magnetic Resonance Observational Study

Weill Medical College of Cornell University

Start Date

3/1/2024

Completion Date

1/1/2030

Summary

STICOS will test the hypothesis that residual jeopardized myocardium, late gadolinium enhancement, and non-ischemic substrate after revascularization is associated with postoperative adverse cardiovascular events such as heart failure , readmission, or death. This study will look at whether certain heart tissue abnormalities seen on MRI scans can help predict serious health problems after heart procedures like stents or bypass surgery.

Detailed Description

iLVSD (ischemic left ventricular dysfunction) is a leading cause of heart failure (HF) and death. It is widely treated via coronary revascularization despite limited understanding of determinants of revascularization response. "Viability" imaging (to differentiate infarcted from salvageable myocardium) has been widely touted as an effective means to predict revascularization response. However prior multicenter trials have derived negative conclusions using heterogenous data with respect to both image modality and analysis. Data by our investigators and others indicate that infarct transmurality on CMR strongly impacts remodeling and prognosis after coronary revascularization. The investigators have also developed new methods (dark-blood late gadolinium enhancement-CMR) to assess infarction and shown ischemia (hypoperfusion) and non-ischemic substrate on CMR to strongly impact LV remodeling. Despite conceptual rationale, utility of multiparametric CMR to elucidate mechanism and determinants of remodeling and differential outcomes after percutaneous and surgical revascularization of iLVSD has yet to be tested. This prospective study will test the hypothesis that residual jeopardized (viable but hypoperfused) myocardium, LGE, and non-ischemic substrate after coronary revascularization (by PCI or CABG) is associated with postoperative adverse cardiovascular events

Eligibility Criteria

Age Range: 18 years to No maximum

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. \-

Interventions

DIAGNOSTIC_TEST

Cardiac Magnetic Resonance Imaging

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Ischemic Left Ventricle Systolic DysfunctionMultivessel Coronary Artery Disease

Locations

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York 11215

United States

New York Presbyterian - Queens

Flushing, New York 11355

United States

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York 10022

United States

MU Vienna Austria

Vienna,

Austria

Libin Cardiovascular Institute

Calgary, Alberta T2N 1N4

Canada

Universite Laval Quebec (CRIUCPQ) Canada

Québec,

Canada

Sunnybrook Health Sciences Centre

Toronto,

Canada

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai,

China

Dedinje Cardiovascular Institute

Belgrade,

Serbia