Myocardial Infarction Clinical Trial
Official title:
National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50%
of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is
the primary objective of the treatment in this context. The symptomatic treatment of the
ventricular failure alone does not allow a reduction of mortality. The immediate prognosis
is not significantly improved by the current standard of care, including early
revascularisation and intra-aortic balloon counterpulsation.
In order to improve the immediate prognosis, it seems necessary to limit the irreversible
myocardial lesions and the systemic inflammatory response induced by an extended myocardial
infarction (complement activation, cytokines production, iNOS expression, etc.). These
objectives may be reached by a more extended utilization and availability of circulatory
assistance methods.
The investigators propose to compare, in a randomised multicenter study, two treatments of
the myocardial infarction with cardiogenic shock among 44 patients:
Standard Treatment versus ECLS-Impella +/- standard treatment.
In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic
pump.
This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a
new amendment has been approved by the EC. This amendment allowed to revise the number of
patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint :
variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level
obtained before the randomization).Showing a more important BNP levels decrease in the
experimental group compared to standard treatment group, the investigators obtain an
indirect argument to show a superior efficacy of the tested strategy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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