STICH3C Cardiac Magnetic Resonance Observational Study (STICOS)

August 14, 2025 updated by: Weill Medical College of Cornell University

STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • Libin Cardiovascular Institute
        • Contact:
  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
  • Serbia
  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Contact:
          • Sandhya Balaram, MD
      • Flushing, New York, United States, 11355
        • Recruiting
        • New York Presbyterian - Queens
        • Contact:
      • New York, New York, United States, 10022
        • Recruiting
        • Weill Cornell Medicine/NewYork Presbyterian Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • CMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Magnetic Resonance Imaging (CMR) Indices
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

August 14, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-09026465
  • 1R01HL170566-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multivessel Coronary Artery Disease

Clinical Trials on Cardiac Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe