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

This study has been terminated.
(Change in business priority)
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT01319760
First received: March 18, 2011
Last updated: May 1, 2013
Last verified: May 2013
March 18, 2011
May 1, 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 ClinicalTrials.gov 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).
Interventional
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
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)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01319760
MINI-AMI G100286
Yes
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