COAT: Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients with preserved infarct zone viability improves left ventricular systolic function and volumes at 6 months follow-up. The secondary purpose is to assess the changes in myocardial tissue characteristics after late percutaneous coronary intervention (PCI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Rapid restoration of blood flow in the infarct-related artery (IRA), one of the cornerstones of contemporary treatment of acute myocardial infarction (MI) prevents myocardial necrosis and its consequences. However, due to late presentation or failed fibrinolytic therapy up to one third of patients have persistently occluded IRA after MI.
Recently, the Occluded Artery Trial (OAT) has demonstrated that percutaneous coronary intervention (PCI) with optimal medical therapy does not reduce the frequency of major adverse events compared to optimal medical therapy alone when performed on days 3-28 post MI in stable patients. Assessment of infarct zone viability was not used as an inclusion/exclusion criterion in the main OAT trial.
Several studies confirm that patients with left ventricular systolic dysfunction and preserved myocardial viability (necrosis transmurality<50% in most segments of the infarct zone) assessed with magnetic resonance imaging benefit from revascularization.
Late opening of the occluded infarct-related artery only in patients with preserved myocardial tissue viability may lead to improvement of left ventricular volumes and function.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Optimal medical therapy Conventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification |
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Drug: Statins
Participants will receive statins.
Drug: ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
|
| Experimental: PCI with optimal medical therapy Conventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification plus percutaneous coronary intervention and coronary stenting |
Drug: Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Drug: Platelet inhibitors
Participants will receive platelet inhibitors.
Drug: Statins
Participants will receive statins.
Drug: ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
Procedure: PCI with stenting
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
|
Outcome Measures
Primary Outcome Measures
- change in systolic wall thickening (SWT) [6 months]
Secondary Outcome Measures
- change in left ventricular ejection fraction (LVEF) [6 months]
- change in wall motion score index (WMSI) [6 months]
- change in left ventricular end-diastolic volume (LVEDV) [6 months]
- change in left ventricular end-systolic volume (LVESV) [6 months]
- myocardial tissue characteristics [3-5 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Enrollment 3-28 days after an acute myocardial infarction.
-
Infarct related artery occlusion (TIMI 0 or 1).
-
High risk: left ventricular ejection fraction (LVEF)<50% or LVEF>50% and proximal coronary occlusion.
-
Preserved infarct zone viability (necrosis transmurality <50% in at least 4 segments out of 17 according to AHA classification).
Exclusion Criteria:
- Unstable clinical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Cardiology | Warsaw | Poland | 04-628 |
Sponsors and Collaborators
- Institute of Cardiology, Warsaw, Poland
Investigators
- Principal Investigator: Lukasz A Malek, M.D. PhD, Institute of Cardiology, Warsaw, Poland
- Study Chair: Mariusz Kruk, M.D. PhD, Institute of Cardiology, Warsaw, Poland
- Study Chair: Mariusz Klopotowski, M.D., Institute of Cardiology, Warsaw, Poland
Study Documents (Full-Text)
None provided.More Information
Publications
- Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. Epub 2006 Nov 14.
- Hochman JS, Lamas GA, Knatterud GL, Buller CE, Dzavik V, Mark DB, Reynolds HR, White HD; Occluded Artery Trial Research Group. Design and methodology of the Occluded Artery Trial (OAT). Am Heart J. 2005 Oct;150(4):627-42.
- Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53.
- Malek LA, Reynolds HR, Forman SA, Vozzi C, Mancini GB, French JK, Dziarmaga M, Renkin JP, Kochman J, Lamas GA, Hochman JS. Late coronary intervention for totally occluded left anterior descending coronary arteries in stable patients after myocardial infarction: Results from the Occluded Artery Trial (OAT). Am Heart J. 2009 Apr;157(4):724-32. doi: 10.1016/j.ahj.2008.12.008.
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