MINI-AMI: Minimizing Infarct Size With Impella 2.5 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)
ST-elevation Myocardial Infarction
Device: Impella 2.5 support
|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|
- 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:
- Major Vascular Complication.
- 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)
- 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)
- Aortic valve injury or dysfunction
- Acute kidney injury.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
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
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).