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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL170566-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
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Inclusion Criteria:
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.
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Patients diagnosed with iLVSD and multivessel coronary artery disease (CAD) undergoing revascularization (PCI or CABG)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC | Contact | 212.746.1812 | sticos@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| NewYork-Presbyterian Brooklyn Methodist Hospital | Recruiting | Brooklyn | New York | 11215 | United States |
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| New York Presbyterian - Queens | Recruiting | Flushing | New York | 11355 | United States |
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| Weill Cornell Medicine/NewYork Presbyterian Hospital | Recruiting | New York | New York | 10022 | United States |
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| MU Vienna Austria | Recruiting | Vienna | Austria |
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| Libin Cardiovascular Institute | Recruiting | Calgary | Alberta | T2N 1N4 | Canada |
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| Universite Laval Quebec (CRIUCPQ) Canada | Recruiting | Québec | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Canada |
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| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Dedinje Cardiovascular Institute | Recruiting | Belgrade | Serbia |
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