IMPella versus IABP REduces mortality in STEMI patients treated with primary PCI IN SEVERE and deep cardiogenic SHOCK. An international multicenter, randomized trial of the Impella cVAD (left ventricular assist) device versus Intra Aortic Balloon Counter Pulsation (IABP) therapy for acute ST-elevation myocardial infarction patients treated with primary PCI in severe and deep cardiogenic shock
Completed
- Conditions
- severe cardiogenic shockseverely depressed heart function1001108210011954
- Registration Number
- NL-OMON39892
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 43
Inclusion Criteria
1 Delay between onset of chest pain and PCI * 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. For this trial we target a patient population with a Ph <7.3 and or lactate levels of around 6 mmol/L.
Exclusion Criteria
1 Severe aorta-iliac arterial disease impeding placement of either devices
2 Known severe cardiac aortic valvular disease
3 Serious known concomitant disease with a life expectancy of less than one year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is 30 day mortality.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints to be compared between the patients treated with<br /><br>Impella cVAD and IABP :<br /><br>* Mortality at 6 months, and at 1 to 5 years of follow up<br /><br>* Composite of death and severe acquired disability after 30 days, 6 months,<br /><br>and at 1 to 5 years of follow up. </p><br>