MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction

Abiomed

Status: Terminated

Conditions: ST-elevation Myocardial Infarction

Treatments: Other: Standard of care (Control); Device: Impella 2.5 support

Study type: Interventional

Funder types: Industry

Identifiers

NCT01319760

MINI-AMI G100286

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Standard of care

Sham Comparator group

Description:

Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction.

Treatment:

Other: Standard of care (Control)

Impella 2.5

Experimental group

Description:

24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.

Treatment:

Device: Impella 2.5 support