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

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 - IMPRESS in severe shock

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39892

Enrollment

Registered

2011-11-17

Start date

2012-06-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe cardiogenic shock severely depressed heart function

Interventions

After primary PCI, patients will be randomized to supportive treatment with either IABP ('routine care') or the Impella cVAD.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is 30 day mortality.	—

Secondary

Measure	Time frame
The secondary endpoints to be compared between the patients treated with Impella cVAD and IABP : * Mortality at 6 months, and at 1 to 5 years of follow up * Composite of death and severe acquired disability after 30 days, 6 months, and at 1 to 5 years of follow up.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)