Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
- Conditions
- Cardiovascular DiseasesHeart FailureMyocardial InfarctionHeart Diseases
- Interventions
- Drug: Beta adrenergic blockersDrug: Platelet inhibitorsDrug: StatinsDrug: ACE inhibitors and/or ARB and/or AAProcedure: PCI with stenting
- Registration Number
- NCT00968383
- Lead Sponsor
- National Institute of Cardiology, Warsaw, Poland
- 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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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).
- Unstable clinical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal medical therapy Statins 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 PCI with optimal medical therapy Beta adrenergic blockers 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 PCI with optimal medical therapy Platelet inhibitors 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 Optimal medical therapy Beta adrenergic blockers 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 Optimal medical therapy Platelet inhibitors 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 PCI with optimal medical therapy PCI with stenting 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 PCI with optimal medical therapy ACE inhibitors and/or ARB and/or AA 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 Optimal medical therapy ACE inhibitors and/or ARB and/or AA 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 PCI with optimal medical therapy Statins 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
- Primary Outcome Measures
Name Time Method change in systolic wall thickening (SWT) 6 months
- Secondary Outcome Measures
Name Time Method change in wall motion score index (WMSI) 6 months myocardial tissue characteristics 3-5 days change in left ventricular ejection fraction (LVEF) 6 months change in left ventricular end-diastolic volume (LVEDV) 6 months change in left ventricular end-systolic volume (LVESV) 6 months
Trial Locations
- Locations (1)
Institute of Cardiology
🇵🇱Warsaw, Poland