STICH3C Cardiac Magnetic Resonance Observational Study

NCT07133984 | Recruiting

• 2 other identifiers: 23-090264651R01HL170566-01
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 9

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.

Conditions

Ischemic Left Ventricle Systolic Dysfunction; Multivessel Coronary Artery Disease

Keywords

iLVSD; CAD; Cardiac MRI

Outcome Measures

Primary Outcomes (1)

• Cardiac Magnetic Resonance Imaging (CMR) Indices

  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.

  5 years

Study Arms (1)

Patients diagnosed with iLVSD and CAD undergoing revascularization.

Eligible patients will be approached by study team before PCI or CABG for consent to participate in the study. For patients in whom the treating physicians have requested or will request pre-procedure CMR for clinical reasons, consent to collect long-term clinical data will be requested. Eligible patients who meet inclusion criteria in whom clinical CMR is not planned, will be asked to undergo preoperative CMR with or without postoperative CMR and to be followed up for research purposes.

Diagnostic Test: Cardiac Magnetic Resonance Imaging

Interventions

Cardiac Magnetic Resonance Imaging DIAGNOSTIC_TEST

Cardiac MRI, also known as cardiac magnetic resonance imaging, is a non-invasive imaging technique that uses strong magnetic fields and radio waves to produce detailed pictures of the heart and its surrounding structures

Also known as: CMR

Patients diagnosed with iLVSD and CAD undergoing revascularization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with iLVSD and multivessel coronary artery disease (CAD) undergoing revascularization (PCI or CABG)

You may qualify if:

• Men and women ≥ 18 years old
• LVEF ≤ 40% (quantified by echo, single-photon emission computed tomography \[SPECT\], or CMR within 2 months of enrollment)
• 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.
• Planned CABG or PCI within 3 months

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (9)

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

New York Presbyterian - Queens

Flushing, New York, 11355, United States

RECRUITING

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York, 10022, United States

RECRUITING

MU Vienna Austria

Vienna, Austria

RECRUITING

Libin Cardiovascular Institute

Calgary, Alberta, T2N 1N4, 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 Officials

• Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC

CONTACT

212.746.1812; sticos@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1); US (3); AU (1); SE (1); CA (3)