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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
NewYork-Presbyterian Brooklyn Methodist Hospital
RECRUITING
Brooklyn
New York Presbyterian - Queens
RECRUITING
Flushing
Weill Cornell Medicine/NewYork Presbyterian Hospital
RECRUITING
New York
Other Locations
Austria
MU Vienna Austria
RECRUITING
Vienna
Canada
Libin Cardiovascular Institute
RECRUITING
Calgary
Universite Laval Quebec (CRIUCPQ) Canada
RECRUITING
Québec
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Serbia
Dedinje Cardiovascular Institute
RECRUITING
Belgrade
Contact Information
Primary
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
sticos@med.cornell.edu
212.746.1812
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2030-01
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov