Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock

Study Overview
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Brief Summary
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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.

Official Title
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National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)

Conditions
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Myocardial Infarction, Shock, Cardiogenic

Intervention / Treatment
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* Device: Extra-Corporeal Life Support -Impella 2.5


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>IABP, inotropic drugs, antiplatelet agents according to site habits. | |
| Experimental: Experimental<br>ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits. | Device: Extra-Corporeal Life Support -Impella 2.5<br>* Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)<br>* Other names: IMPELLA LP 2.5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP levels measured at H6, H12, H48 and H72. |  | one month | 
| 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 | 
| Infarct size at 1 month and 4 months. |  | 4 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Cardiogenic shock, Extracorporeal Life Support-Impella