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

NCT ID: NCT01319760

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-03-31

Brief 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)

Detailed 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.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

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.

Group Type: SHAM_COMPARATOR

Standard of care (Control)

Intervention Type: OTHER

Standard care for STEMI patients post-PCI from ACC/AHA Guidelines

Impella 2.5

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

Group Type: EXPERIMENTAL

Impella 2.5 support

Intervention Type: DEVICE

Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5

Interventions

Impella 2.5 support

Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5

Intervention Type: DEVICE

Standard of care (Control)

Standard care for STEMI patients post-PCI from ACC/AHA Guidelines

Intervention Type: OTHER

Other Intervention Names

Impella LP 2.5

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Moses, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Presbyterian

Ajay Kirtane, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Presbyterian

Other Identifiers

MINI-AMI G100286

Identifier Type: -

Identifier Source: org_study_id