Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock
NCT ID: NCT00314847
Last Updated: 2010-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2005-06-30
2009-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
IABP, inotropic drugs, antiplatelet agents according to site habits.
No interventions assigned to this group
Experimental
ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient without contraindication to IABP or ECLS-Impella
Exclusion Criteria
* Reperfusion \> 24 hours after the pain begins
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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University Hospital of Caen
Principal Investigators
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Massimo Massetti, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
Rémi Sabatier, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
Locations
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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
Pitié-Salpétrière Hospital
Paris, , France
Cochin Hospital
Paris, , France
Hôpital Haut-Lévèque
Pessac, , France
Hôpital Charles Nicolle
Rouen, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Toulouse University Hospital
Toulouse, , France
Countries
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Other Identifiers
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ECLS
Identifier Type: -
Identifier Source: org_study_id
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