Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07133984

Conditions

Ischemic Left Ventricle Systolic Dysfunction

Multivessel Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Magnetic Resonance Imaging

Study Details

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

Study ID

NCT07133984

Start date

Mar 1, 2024

Status verified date

Aug, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiac Magnetic Resonance Imaging

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

Primary outcome measure

  • Cardiac Magnetic Resonance Imaging (CMR) Indices [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

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

212.746.1812sticos@med.cornell.edu

Locations

NewYork-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

New York Presbyterian - Queens

Recruiting

Flushing, New York, United States, 11355

Contacts

Weill Cornell Medicine/NewYork Presbyterian Hospital

Recruiting

New York, New York, United States, 10022

Contacts

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

212 746 1812mfg9004@med.cornell.edu

Libin Cardiovascular Institute

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Universite Laval Quebec (CRIUCPQ) Canada

Recruiting

Québec, Canada

Contacts

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Canada

Contacts

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Keywords

  • iLVSD
  • CAD
  • Cardiac MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-08-21.