Acute Myocardial Infarction
Conditions
Keywords
Arterial Occlusive Disease, Heart Diseases, Myocardial Ischemia, Vascular Disease, Arteriosclerosis, Ischemia
Brief summary
This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.
Interventions
DEVICEImpella LP 2.5
Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5L/min.
The Intra-Aortic Balloon Pump consists of a cylindrical balloon that sits in the aorta and counterpulsates.
Sponsors
Abiomed Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Subject presenting with STEMI undergoing primary PCI * Patient presents with at least 1 of the following: * Unstable blood pressure * Tachycardia and tissue hypoperfusion * The need for intravenous pressor or inotropic support * Patient presents with STEMI: * CK-MB\>2x normal
Exclusion criteria
* Unwitnessed cardiac arrest * Abnormalities of the aorta * Recent stroke or TIA * Mural thrombus in the left ventricle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of major adverse events within 30 days or hospital discharge. | 30 days or discharge | Composite rate of major adverse events within 30 days or hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum CPO increase from baseline. | Treatment | Maximum CPO increase from baseline. |
Countries
United States
Outcome results
None listed