Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure
Conditions
Keywords
Acute Coronary Syndrome, Myocardial infarction, Infarct Related Artery, Percutaneous Coronary Intervention, Medical treatment, Tissue Viability, Magnetic Resonance
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.
Interventions
Participants will receive beta adrenergic blockers.
Participants will receive platelet inhibitors.
DRUGStatins
Participants will receive statins.
DRUGACE inhibitors and/or ARB and/or AA
Participants will receive ACE inhibitors and/or ARB and/or AA
PROCEDUREPCI with stenting
Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in systolic wall thickening (SWT) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| change in wall motion score index (WMSI) | 6 months |
| change in left ventricular end-diastolic volume (LVEDV) | 6 months |
| change in left ventricular ejection fraction (LVEF) | 6 months |
| change in left ventricular end-systolic volume (LVESV) | 6 months |
| myocardial tissue characteristics | 3-5 days |
Countries
Poland
Outcome results
None listed