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

Caen University Hospital

Status and phase: Terminated; Phase 4

Conditions: Myocardial Infarction; Shock, Cardiogenic

Treatments: Device: Extra-Corporeal Life Support -Impella 2.5

Study type: Interventional

Funder types: Other

Identifiers

NCT00314847

ECLS

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Control

No Intervention group

Description:

IABP, inotropic drugs, antiplatelet agents according to site habits.

Experimental

Experimental group

Description:

ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits.

Treatment:

Device: Extra-Corporeal Life Support -Impella 2.5