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

July 30, 2010 updated by: University Hospital, Caen

National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29000
        • Brest University Hospital
      • Caen, France, 14000
        • Caen University Hospital
      • Clermont-Ferrand, France, 63000
        • Clermont-Ferrand University Hospital
      • Lyon, France, 69317
        • Hôpital de la Croix Rousse
      • Marseille, France, 13008
        • Hôpital de la Timone
      • Massy, France
        • Paris Sud Cardiovascular Institute
      • Mulhouse, France, 68000
        • Mulhouse Hospital
      • Paris, France, 75013
        • Pitié-Salpêtrière Hospital
      • Paris, France
        • Cochin Hospital
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque
      • Rouen, France
        • Hôpital Charles Nicolle
      • Saint-Denis, France, 93207
        • Centre Cardiologique du Nord
      • Toulouse, France, 31000
        • Toulouse University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • IMPELLA LP 2.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
BNP levels measured at H6, H12, H48 and H72.
Time Frame: one month
one month
BNP level measured at H48 after assistance weaning.
Time Frame: one month
one month
haemoglobin levels
Time Frame: one month
one month
lactate levels
Time Frame: one month
one month
creatinine levels
Time Frame: one month
one month
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
one month
Mortality at Day 30, at 6 months, at 1 year.
Time Frame: one year
one year
Infarct size at 1 month and 4 months.
Time Frame: 4 months
4 months
Amines maximal dose
Time Frame: one month
one month
Cardiologic treatments outside the hospital
Time Frame: one year
one year
Assistance last
Time Frame: one month
one month
mechanical ventilation last
Time Frame: one month
one month
assistance weaning failure
Time Frame: one month
one month
haemorrhagic, ischemic and septic complications.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Rémi Sabatier, MD, University Hospital, Caen
  • Principal Investigator: Massimo Massetti, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 2, 2010

Last Update Submitted That Met QC Criteria

July 30, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECLS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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