MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction (MINI-AMI)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|