Heart Failure Clinical Trial
Official title:
Late Percutaneous Coronary Intervention of the Occluded Infarct-Related Artery in Patients With Preserved Infarct Zone Viability Determined With Magnetic Resonance Imaging
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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