STICH3C Cardiac Magnetic Resonance Observational Study

ConditionsIschemic Left Ventricle Systolic Dysfunction Multivessel Coronary Artery Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Either planned CABG/PCI within 3 months or CABG/PCI within the last 9 months.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

230 Participants

are divided into 1 treatment group

Group A: Patients diagnosed with iLVSD and CAD undergoing revascularization.1 intervention

Trial outcomes

Primary outcomes

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. This is measured by residual jeopardized (viable but hypoperfused) myocardium, LGE, and nonischemic substrate after PCI or CABG independently predict impaired clinical events such as HF readmission or death.

Time frame

5 years