mini-ami: minimizing infarct size with impella 2.5 following pci for acute myocardial infarction

Conditions: ST-elevation Myocardial Infarction

Summary: a prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the impella® 2.5 system in reducing infarct size in patients with st-elevation myocardial infarction (stemi)

the primary objective of this study is to evaluate whether the adjunctive use of the impella® 2.5 system for 24 hours following primary pci for stemi has the potential to limit the infarction of at-risk myocardium compared to primary pci with routine post-pci care (standard of care). this study is a feasibility study. therefore, the principal objective is to identify trends in cardiac magnetic resonance imaging (mri)-based efficacy outcomes between the randomized treatment arms (impella arm compared standard of care.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * acute anterior stemi with ≥2 mm of st-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, or, large inferior stemi with ≥2 mm of st-segment elevation in 2 or more inferior leads and either ≥1 mm st-segment elevation in v1 or ≥1 mm of st-segment depression in ≥2 contiguous anterior leads (v1-v3) * primary pci performed within 5 hours of the onset of symptoms * patient undergoing emergent primary pci of one culprit lesion in one major native epicardial coronary vessel * successful revascularization of the culprit native coronary artery with timi flow grade of 3 at the end of pci exclusion criteria: * cardiac arrest requiring cpr within 24 hours prior to enrollment * current cardiogenic shock * left bundle branch block (new or old) * atrial fibrillation * known history of prior mi * prior coronary artery bypass graft surgery * known mural thrombus in the left ventricle or contraindication to left ventriculography * presence of a mechanical aortic valve * documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency. * known history of severe kidney dysfunction. * known contraindication to mri (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds). * history of recent (within 1 month) stroke or tia * history of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions. * administration of fibrinolytic therapy within 24 hours * known hypersensitivity or contraindication to any of the following: heparin, pork or pork products; aspirin, all of the following: clopidogrel, ticlopidine, prasugrel * contrast media participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device. * severe peripheral arterial obstructive disease that would preclude the impella® system placement * requirement to treat two or more culprit vessels during primary pci, or plan for staged coronary revascularization (pci or cabg) within the next 30 days. * inability to place impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.

Keywords: stemi