Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
NCT ID: NCT00968383
Last Updated: 2015-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2009-09-30
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Platelet inhibitors
Participants will receive platelet inhibitors.
Statins
Participants will receive statins.
ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
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
Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Platelet inhibitors
Participants will receive platelet inhibitors.
Statins
Participants will receive statins.
ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
PCI with stenting
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
Interventions
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Beta adrenergic blockers
Participants will receive beta adrenergic blockers.
Platelet inhibitors
Participants will receive platelet inhibitors.
Statins
Participants will receive statins.
ACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
PCI with stenting
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Principal Investigators
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Lukasz A Malek, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiology, Warsaw, Poland
Mariusz Kruk, M.D. PhD
Role: STUDY_CHAIR
National Institute of Cardiology, Warsaw, Poland
Mariusz Klopotowski, M.D.
Role: STUDY_CHAIR
National Institute of Cardiology, Warsaw, Poland
Locations
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Institute of Cardiology
Warsaw, , Poland
Countries
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References
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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. doi: 10.1016/j.ahj.2005.07.002.
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. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.
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.
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. doi: 10.1056/NEJM200011163432003.
Malek LA, Silva JC, Bellenger NG, Nicolau JC, Klopotowski M, Spiewak M, Rassi CH, Lewandowski Z, Kruk M, Rochitte CE, Ruzyllo W, Witkowski A. Late percutaneous coronary intervention for an occluded infarct-related artery in patients with preserved infarct zone viability: a pooled analysis of cardiovascular magnetic resonance studies. Cardiol J. 2013;20(5):552-9. doi: 10.5603/CJ.2013.0141.
Other Identifiers
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2.50/V/09
Identifier Type: -
Identifier Source: org_study_id
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