Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock
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.
|Myocardial Infarction Shock, Cardiogenic||Device: Extra-Corporeal Life Support -Impella 2.5||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization). [ Time Frame: one month ]
- BNP levels measured at H6, H12, H48 and H72. [ Time Frame: one month ]
- BNP level measured at H48 after assistance weaning. [ Time Frame: one month ]
- haemoglobin levels [ Time Frame: one month ]
- lactate levels [ Time Frame: one month ]
- creatinine levels [ Time Frame: one month ]
- Mortality at day 30 or Evolution to a refractory cardiogenic shock requiring an intra-thoracic ventricular assistance or an ECMO (ECLS-Impella group) and all types of ventricular assistance (IAPB group) or a cardiac graft within 30 days. [ Time Frame: one month ]
- Mortality at Day 30, at 6 months, at 1 year. [ Time Frame: one year ]
- Infarct size at 1 month and 4 months. [ Time Frame: 4 months ]
- Amines maximal dose [ Time Frame: one month ]
- Cardiologic treatments outside the hospital [ Time Frame: one year ]
- Assistance last [ Time Frame: one month ]
- mechanical ventilation last [ Time Frame: one month ]
- assistance weaning failure [ Time Frame: one month ]
- haemorrhagic, ischemic and septic complications. [ Time Frame: six months ]
|Study Start Date:||June 2005|
|Study Completion Date:||October 2009|
No Intervention: Control
IABP, inotropic drugs, antiplatelet agents according to site habits.
ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits.
Device: Extra-Corporeal Life Support -Impella 2.5
Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)
Other Name: IMPELLA LP 2.5
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314847
|Brest University Hospital|
|Brest, France, 29000|
|Caen University Hospital|
|Caen, France, 14000|
|Clermont-Ferrand University Hospital|
|Clermont-Ferrand, France, 63000|
|Hôpital de la Croix Rousse|
|Lyon, France, 69317|
|Hôpital de la Timone|
|Marseille, France, 13008|
|Paris Sud Cardiovascular Institute|
|Mulhouse, France, 68000|
|Paris, France, 75013|
|Pessac, France, 33604|
|Hôpital Charles Nicolle|
|Centre Cardiologique du Nord|
|Saint-Denis, France, 93207|
|Toulouse University Hospital|
|Toulouse, France, 31000|
|Principal Investigator:||Massimo Massetti, MD||University Hospital, Caen|
|Principal Investigator:||Rémi Sabatier, MD||University Hospital, Caen|