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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01319760
Recruitment Status : Terminated (Change in business priority)
First Posted : March 22, 2011
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
Abiomed Inc.

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)

Condition or disease Intervention/treatment Phase
ST-elevation Myocardial Infarction Device: Impella 2.5 support Other: Standard of care (Control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
Study Start Date : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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 Name: Impella LP 2.5

Primary Outcome Measures :
  1. Infarct Size [ Time Frame: 3-5 Days post infarct ]
    Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).

  2. No Data for Primary or Secondary Enpoints Were Collected [ Time Frame: No data for primary or secondary enpoints were collected ]

Secondary Outcome Measures :
  1. Infarct Size [ Time Frame: 90 Days ]
    Assessment of infarct size and remodeling characteristics at 90 days post-infarct.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01319760

Sponsors and Collaborators
Abiomed Inc.
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Principal Investigator: Jeffrey Moses, MD Columbia Presbyterian
Principal Investigator: Ajay Kirtane, MD Columbia Presbyterian
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Responsible Party: Abiomed Inc. Identifier: NCT01319760    
Other Study ID Numbers: MINI-AMI G100286
First Posted: March 22, 2011    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: April 2019
Keywords provided by Abiomed Inc.:
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases