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
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
Abiomed Inc.

March 18, 2011
March 22, 2011
May 3, 2013
April 2011
March 2013   (Final data collection date for primary outcome measure)
  • Infarct size [ Time Frame: 3-5 Days post infarct ]
    Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
  • MACCE [ Time Frame: 30 days or discharge, whichever is longer ]

    A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days or discharge, whichever is longer:

    • Mortality
    • Reinfarction
    • Stroke/TIA
    • Major Vascular Complication.
Same as current
Complete list of historical versions of study NCT01319760 on Archive Site
  • Infarct size [ Time Frame: 90 days ]
    Assessment of infarct size and remodeling characteristics at 90 days post-infarct
  • Major Adverse Events [ Time Frame: 30 days or discharge, whichever is longer ]
    • Mortality (Cardiovascular and Non-Cardiovascular)
    • Reinfarction
    • Stroke/TIA
    • Vascular Complications (sub-categorized as either Major or Minor)
    • Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support
    • Repeat revascularization
    • Bleeding (sub-categorized)
    • Hematoma
    • Hemolysis
    • Aortic valve injury or dysfunction
    • Acute kidney injury.
Same as current
Not Provided
Not Provided
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
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)
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 to control).
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
ST-elevation 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
  • Other: Control
    Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
    Other Name: Standard of care
  • Control
    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.
    Intervention: Other: Control
  • Experimental: Impella 2.5
    Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.
    Intervention: Device: Impella 2.5 support
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
MINI-AMI G100286
Not Provided
Not Provided
Abiomed Inc.
Abiomed Inc.
Not Provided
Principal Investigator: Jeffrey Moses, MD Columbia Presbyterian
Principal Investigator: Ajay Kirtane, MD Columbia Presbyterian
Abiomed Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP