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

MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction

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)

Study Overview

• Status: Terminated
• Conditions: ST-elevation Myocardial Infarction
• Intervention / Treatment: Other: Standard of care (Control); Device: Impella 2.5 support

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: 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.	Other: Standard of care (Control); Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
EXPERIMENTAL: Impella 2.5; 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.	Device: Impella 2.5 support; Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5; Other Names: Impella LP 2.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct Size	Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).	3-5 Days post infarct
No Data for Primary or Secondary Enpoints Were Collected		No data for primary or secondary enpoints were collected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct Size	Assessment of infarct size and remodeling characteristics at 90 days post-infarct.	90 Days

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Principal Investigator: Jeffrey Moses, MD, Columbia Presbyterian; Principal Investigator: Ajay Kirtane, MD, Columbia Presbyterian

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (ESTIMATE): March 22, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: STEMI
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: MINI-AMI G100286