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Trial record 1 of 1 for:    NCT00314847
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Comparison of Standard Treatment Versus Standard Treatment Plus Extracorporeal Life Support (ECLS) in Myocardial Infarction Complicated With Cardiogenic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314847
Recruitment Status : Terminated (The study was stopped prematurely due to insufficient recruitment)
First Posted : April 17, 2006
Last Update Posted : August 2, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Shock, Cardiogenic Device: Extra-Corporeal Life Support -Impella 2.5 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
No Intervention: Control
IABP, inotropic drugs, antiplatelet agents according to site habits.
Experimental: Experimental
ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits.
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)
Other Name: IMPELLA LP 2.5

Primary Outcome Measures :
  1. Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization). [ Time Frame: one month ]

Secondary Outcome Measures :
  1. BNP levels measured at H6, H12, H48 and H72. [ Time Frame: one month ]
  2. BNP level measured at H48 after assistance weaning. [ Time Frame: one month ]
  3. haemoglobin levels [ Time Frame: one month ]
  4. lactate levels [ Time Frame: one month ]
  5. creatinine levels [ Time Frame: one month ]
  6. 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. [ Time Frame: one month ]
  7. Mortality at Day 30, at 6 months, at 1 year. [ Time Frame: one year ]
  8. Infarct size at 1 month and 4 months. [ Time Frame: 4 months ]
  9. Amines maximal dose [ Time Frame: one month ]
  10. Cardiologic treatments outside the hospital [ Time Frame: one year ]
  11. Assistance last [ Time Frame: one month ]
  12. mechanical ventilation last [ Time Frame: one month ]
  13. assistance weaning failure [ Time Frame: one month ]
  14. haemorrhagic, ischemic and septic complications. [ Time Frame: six months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314847

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Brest University Hospital
Brest, France, 29000
Caen University Hospital
Caen, France, 14000
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63000
Hôpital de la Croix Rousse
Lyon, France, 69317
Hôpital de la Timone
Marseille, France, 13008
Paris Sud Cardiovascular Institute
Massy, France
Mulhouse Hospital
Mulhouse, France, 68000
Pitié-Salpétrière Hospital
Paris, France, 75013
Cochin Hospital
Paris, France
Hôpital Haut-Lévèque
Pessac, France, 33604
Hôpital Charles Nicolle
Rouen, France
Centre Cardiologique du Nord
Saint-Denis, France, 93207
Toulouse University Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Caen
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Principal Investigator: Massimo Massetti, MD University Hospital, Caen
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen

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Responsible Party: M. Piquemal, University Hospital of Caen Identifier: NCT00314847    
Other Study ID Numbers: ECLS
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: August 2, 2010
Last Verified: July 2010
Keywords provided by University Hospital, Caen:
Myocardial infarction
Cardiogenic shock
Extracorporeal Life Support-Impella
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases