STICH3C Cardiac Magnetic Resonance Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Ischemic Left Ventricle Systolic Dysfunction, Multivessel Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, China, Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)
Overview
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
Interventions
- 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
Primary outcome measures
- Cardiac Magnetic Resonance Imaging (CMR) Indices [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn
- New York Presbyterian - Queens — Flushing
- Weill Cornell Medicine/NewYork Presbyterian Hospital — New York
Canada · 3 centers
- Libin Cardiovascular Institute — Calgary
- Universite Laval Quebec (CRIUCPQ) Canada — Québec
- Sunnybrook Health Sciences Centre — Toronto
Austria · 1 center
- MU Vienna Austria — Vienna
China · 1 center
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
Serbia · 1 center
- Dedinje Cardiovascular Institute — Belgrade
Identifiers
NCT: NCT07133984 · 23-09026465 · 1R01HL170566-01