Clinical trial NCT00314847: Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Infarction
Shock, Cardiogenic
Keywords: Myocardial infarction
Cardiogenic shock
Extracorporeal Life Support-Impella
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2006-04-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization).
timeFrame: one month
Secondary outcomes:
measure: BNP levels measured at H6, H12, H48 and H72.
timeFrame: one month
measure: BNP level measured at H48 after assistance weaning.
timeFrame: one month
measure: haemoglobin levels
timeFrame: one month
measure: lactate levels
timeFrame: one month
measure: creatinine levels
timeFrame: one month
measure: 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.
timeFrame: one month
measure: Mortality at Day 30, at 6 months, at 1 year.
timeFrame: one year
measure: Infarct size at 1 month and 4 months.
timeFrame: 4 months
measure: Amines maximal dose
timeFrame: one month
measure: Cardiologic treatments outside the hospital
timeFrame: one year
measure: Assistance last
timeFrame: one month
measure: mechanical ventilation last
timeFrame: one month
measure: assistance weaning failure
timeFrame: one month
measure: haemorrhagic, ischemic and septic complications.
timeFrame: six months
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Hôpital de la Timone
city: Massy
country: France
facility: Paris Sud Cardiovascular Institute
city: Mulhouse
country: France
facility: Mulhouse Hospital
city: Paris
country: France
facility: Pitié-Salpétrière Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Massimo Massetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Rémi Sabatier, MD
role: PRINCIPAL_INVESTIGATOR
References: