Back to resultsMINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction (MINI-AMI)
Primary Purpose
ST-elevation Myocardial Infarction
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Impella 2.5 support
Standard of care (Control)
Sponsored by
About this trial
This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring STEMI
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Standard of care
Impella 2.5
Arm Description
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.
24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.
Outcomes
Primary Outcome Measures
Infarct Size
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
No Data for Primary or Secondary Enpoints Were Collected
Secondary Outcome Measures
Infarct Size
Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01319760
Brief Title
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
Acronym
MINI-AMI
Official Title
MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Change in business priority
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
STEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Impella 2.5
Arm Type
Experimental
Arm Description
24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.
Intervention Type
Device
Intervention Name(s)
Impella 2.5 support
Other Intervention Name(s)
Impella LP 2.5
Intervention Description
Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5
Intervention Type
Other
Intervention Name(s)
Standard of care (Control)
Intervention Description
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
Primary Outcome Measure Information:
Title
Infarct Size
Description
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
Time Frame
3-5 Days post infarct
Title
No Data for Primary or Secondary Enpoints Were Collected
Time Frame
No data for primary or secondary enpoints were collected
Secondary Outcome Measure Information:
Title
Infarct Size
Description
Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Moses, MD
Organizational Affiliation
Columbia Presbyterian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD
Organizational Affiliation
Columbia Presbyterian
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
We'll reach out to this number within 24 hrs