acute myocardial infarction cardiogenic shock
Conditions
Interventions
Patients in cardiogenic shock after ST-elevation myocardial infarction, treated by primary PCI, are randomized to either treatment with the Impella cVAD device or to standard treatment with IABP (intr
Sponsors
Academic Medical Center, Departement of Cardiology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Delay between onset of chest pain and PCI ≤ 24-72 hours; 2. Cardiogenic shock defined as: systolic blood pressure ≤ 90 mmHg for > 30 minutes or the need for supportive measures to maintain a systolic blood pressure ≥ 90 mmHg; 3. In order to ensure the most extremist category of cardiogenic shock, only patients who are already mechanically ventilated will be enrolled.
Exclusion criteria
Exclusion criteria: 1. Severe aorta-iliac arterial disease impeding placement of either devices; 2. Known severe cardiac aortic valvular disease; 3. Known participation in this study or any other trial within the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day mortality rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality after 6 months, and at 1 to 5 years of follow up; 2. Composite of death and severe acquired disability after 6 months, and at 1 to 5 years of follow up. | — |
Contacts
Public ContactJ.P.S Henriques
Academic Medical Center-University of Amsterdam, Department of Cardiology, room B2-116 Meibergdreef 9
Outcome results
None listed