The primary objective of this study is to determine whether the Impella cVAD device vs. IABP therapy leads to a higher 30 day survival rate in shock STEMI patients in the setting of primary PCI.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is 30 day mortality.
Secondary outcome
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.
Background summary
Restoration of antegrade flow in the infarct related coronary artery
(reperfusion) is the cornerstone treatment of acute ST segment elevation
myocardial infarction (STEMI). Reperfusion therapy reduces myocardial damage
and therefore mortality. Cardiogenic Shock STEMI patients treated with primary
PCI still have a high mortality despite adequate reperfusion and intra aortic
counter pulsation therapy (IABP).
Mechanical support of the left ventricle provides may increase survival of the
patients. The IABP offers 'passive' support; its function is dependant on left
ventricular function. The Impella cVAD provides active support, by pumping
blood from the left ventricle into the ascending aorta, thereby unloading the
left ventricle. This may reduce infarct size and improve survival.
Study objective
The primary objective of this study is to determine whether the Impella cVAD
device vs. IABP therapy leads to a higher 30 day survival rate in shock STEMI
patients in the setting of primary PCI.
Study design
An international multicenter, prospective, randomized, two-arm, open label
trial.
Intervention
After primary PCI, patients will be randomized to supportive treatment with
either IABP ('routine care') or the Impella cVAD.
Study burden and risks
Patients randomized to treatment with the Impella cVAD are at risk of damage of
the bloodvessel wall, through which the Impella is inserted. This may result in
a deficiency of blood supply to the involved leg. However, we believe that the
potential benefits offset the possible risks. STEMI patients with cardiogenic
shock represent a patient population at high risk for mortality, despite
revascularization with primary PCI and support with IABP. Treatment with the
Impella cVAD may reduce mortality in such patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37515.018.11 |