RECRUITING

STICH3C Cardiac Magnetic Resonance Observational Study

Conditions

Ischemic Left Ventricle Systolic Dysfunction Multivessel Coronary Artery Disease iLVSD CAD Cardiac MRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07133984

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

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

CONTACT

212.746.1812

sticos@med.cornell.edu

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-03-01

Study Completion Date2030-01

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

iLVSD
CAD
Cardiac MRI

Additional Relevant MeSH Terms

Ischemic Left Ventricle Systolic Dysfunction
Multivessel Coronary Artery Disease