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

Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00314847
• Other study ID #: ECLS
• Status: Terminated
• Phase: Phase 4
• First received: April 13, 2006
• Last updated: July 30, 2010
• Start date: June 2005
• Est. completion date: October 2009

Study information

• Verified date: July 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Extra-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)

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Caen University Hospital	Caen
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital de la Timone	Marseille
France	Paris Sud Cardiovascular Institute	Massy
France	Mulhouse Hospital	Mulhouse
France	Cochin Hospital	Paris
France	Pitié-Salpétrière Hospital	Paris
France	Hôpital Haut-Lévèque	Pessac
France	Hôpital Charles Nicolle	Rouen
France	Centre Cardiologique du Nord	Saint-Denis
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization).		one month	No
Secondary	BNP levels measured at H6, H12, H48 and H72.		one month	No
Secondary	BNP level measured at H48 after assistance weaning.		one month	No
Secondary	haemoglobin levels		one month	No
Secondary	lactate levels		one month	No
Secondary	creatinine levels		one month	No
Secondary	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	No
Secondary	Mortality at Day 30, at 6 months, at 1 year.		one year	No
Secondary	Infarct size at 1 month and 4 months.		4 months	No
Secondary	Amines maximal dose		one month	No
Secondary	Cardiologic treatments outside the hospital		one year	No
Secondary	Assistance last		one month	No
Secondary	mechanical ventilation last		one month	No
Secondary	assistance weaning failure		one month	No
Secondary	haemorrhagic, ischemic and septic complications.		six months	No