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

This study has been terminated.
(The study was stopped prematurely due to insufficient recruitment)
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00314847
First received: April 13, 2006
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Myocardial Infarction
Shock, Cardiogenic
Device: Extra-Corporeal Life Support -Impella 2.5
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BNP levels measured at H6, H12, H48 and H72. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • BNP level measured at H48 after assistance weaning. [ Time Frame: one month ] [ Designated as safety issue: No ]
  • haemoglobin levels [ Time Frame: one month ] [ Designated as safety issue: No ]
  • lactate levels [ Time Frame: one month ] [ Designated as safety issue: No ]
  • creatinine levels [ Time Frame: one month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mortality at Day 30, at 6 months, at 1 year. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Infarct size at 1 month and 4 months. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Amines maximal dose [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Cardiologic treatments outside the hospital [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Assistance last [ Time Frame: one month ] [ Designated as safety issue: No ]
  • mechanical ventilation last [ Time Frame: one month ] [ Designated as safety issue: No ]
  • assistance weaning failure [ Time Frame: one month ] [ Designated as safety issue: No ]
  • haemorrhagic, ischemic and septic complications. [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: June 2005
Study Completion Date: October 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314847

Locations
France
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
Investigators
Principal Investigator: Massimo Massetti, MD University Hospital, Caen
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: M. Piquemal, University Hospital of Caen
ClinicalTrials.gov Identifier: NCT00314847     History of Changes
Other Study ID Numbers: ECLS
Study First Received: April 13, 2006
Last Updated: July 30, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Myocardial infarction
Cardiogenic shock
Extracorporeal Life Support-Impella

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Shock
Shock, Cardiogenic
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014