Myocardial Infarction, Shock, Cardiogenic
Conditions
Keywords
Myocardial infarction, Cardiogenic shock, Extracorporeal Life Support-Impella
Brief summary
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.
Interventions
DEVICEExtra-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)
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction complicated with cardiogenic shock * Patient without contraindication to IABP or ECLS-Impella
Exclusion criteria
* Patient with refractory cardiogenic shock * Reperfusion \> 24 hours after the pain begins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization). | one month |
Secondary
| Measure | Time frame |
|---|---|
| BNP level measured at H48 after assistance weaning. | one month |
| haemoglobin levels | one month |
| lactate levels | one month |
| creatinine levels | 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. | one month |
| Mortality at Day 30, at 6 months, at 1 year. | one year |
| BNP levels measured at H6, H12, H48 and H72. | one month |
| Amines maximal dose | one month |
| Cardiologic treatments outside the hospital | one year |
| Assistance last | one month |
| mechanical ventilation last | one month |
| assistance weaning failure | one month |
| haemorrhagic, ischemic and septic complications. | six months |
| Infarct size at 1 month and 4 months. | 4 months |
Countries
France
Outcome results
None listed