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
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|ST-elevation Myocardial Infarction||Device: Impella 2.5 support Other: Standard of care (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|
|Actual Study Completion Date :||March 2013|
Sham Comparator: Standard of care
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: Standard of care (Control)
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
Experimental: Impella 2.5
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).
- No Data for Primary or Secondary Enpoints Were Collected [ Time Frame: No data for primary or secondary enpoints were collected ]
- Infarct Size [ Time Frame: 90 Days ]Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
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|