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

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
  Purpose

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 Intervention
ST-elevation Myocardial Infarction
Device: Impella 2.5 support
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • Infarct size [ Time Frame: 3-5 Days post infarct ] [ Designated as safety issue: No ]
    Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).

  • MACCE [ Time Frame: 30 days or discharge, whichever is longer ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Infarct size [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Assessment of infarct size and remodeling characteristics at 90 days post-infarct

  • Major Adverse Events [ Time Frame: 30 days or discharge, whichever is longer ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 5
Study Start Date: April 2011
Estimated Study Completion Date: August 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Control
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
Other Name: Standard of care
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.
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

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 to control).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319760

Sponsors and Collaborators
Abiomed Inc.
Investigators
Principal Investigator: Jeffrey Moses, MD Columbia Presbyterian
Principal Investigator: Ajay Kirtane, MD Columbia Presbyterian
  More Information

No publications provided

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT01319760     History of Changes
Other Study ID Numbers: MINI-AMI G100286
Study First Received: March 18, 2011
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abiomed Inc.:
STEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014