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
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, see Learn About Clinical Studies.

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 September 18, 2014