STICH3C Cardiac Magnetic Resonance Observational Study

Recruiting

• Conditions: Ischemic Left Ventricle Systolic Dysfunction; Multivessel Coronary Artery Disease

• Registration Number: NCT07133984
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2028-08
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac Magnetic Resonance Imaging (CMR) Indices	5 years	The primary objective of this study is to relate Cardiac Magnetic Resonance Imaging (CMR) (infarction, perfusion, and nonischemic substrate) after iLVSD revascularization with long-term outcomes.

Trial Locations

Locations (9)

NewYork-Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

New York Presbyterian - Queens; 🇺🇸 Flushing, New York, United States

Weill Cornell Medicine/NewYork Presbyterian Hospital; 🇺🇸 New York, New York, United States

MU Vienna Austria; 🇦🇹 Vienna, Austria

Libin Cardiovascular Institute; 🇨🇦 Calgary, Alberta, Canada

Universite Laval Quebec (CRIUCPQ) Canada; 🇨🇦 Quebec, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Canada

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Dedinje Cardiovascular Institute; 🇷🇸 Belgrade, Serbia