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

Phase 4

Terminated

• Conditions: Myocardial Infarction; Shock, Cardiogenic
• Interventions: Device: Extra-Corporeal Life Support -Impella 2.5

• Registration Number: NCT00314847
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-14
• Study First Posted: 2006-04-17
• Study Completion: 2009-10
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-30
• Last Update Posted: 2010-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Extra-Corporeal Life Support -Impella 2.5	ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (13)

Cochin Hospital; 🇫🇷 Paris, France

Paris Sud Cardiovascular Institute; 🇫🇷 Massy, France

Pitié-Salpétrière Hospital; 🇫🇷 Paris, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Caen University Hospital; 🇫🇷 Caen, France

Hôpital Haut-Lévèque; 🇫🇷 Pessac, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Brest University Hospital; 🇫🇷 Brest, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Mulhouse Hospital; 🇫🇷 Mulhouse, France