MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction (MINI-AMI)
|ClinicalTrials.gov Identifier: NCT01319760|
Recruitment Status : Terminated (Change in business priority)
First Posted : March 22, 2011
Last Update Posted : May 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|ST-elevation Myocardial Infarction||Device: Impella 2.5 support Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||August 2013|
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
- 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:
- Major Vascular Complication.
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319760
|Principal Investigator:||Jeffrey Moses, MD||Columbia Presbyterian|
|Principal Investigator:||Ajay Kirtane, MD||Columbia Presbyterian|