NCT00314847

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 2, 2010

Status Verified

July 1, 2010

First QC Date

April 13, 2006

Last Update Submit

July 30, 2010

Conditions

Myocardial InfarctionShock, Cardiogenic

Keywords

Myocardial infarctionCardiogenic shockExtracorporeal Life Support-Impella

Outcome Measures

Primary Outcomes (1)

  • Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization).

    one month

Secondary Outcomes (14)

  • BNP levels measured at H6, H12, H48 and H72.

    one month

  • BNP level measured at H48 after assistance weaning.

    one month

  • haemoglobin levels

    one month

  • lactate levels

    one month

  • creatinine levels

    one month

  • +9 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Interventions

Extra-Corporeal Life Support -Impella 2.5DEVICE

Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended)

Also known as: IMPELLA LP 2.5
Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction complicated with cardiogenic shock
  • Patient without contraindication to IABP or ECLS-Impella

You may not qualify if:

  • Patient with refractory cardiogenic shock
  • Reperfusion \> 24 hours after the pain begins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Brest University Hospital

Brest, 29000, France

Location

Caen University Hospital

Caen, 14000, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Hôpital de la Timone

Marseille, 13008, France

Location

Paris Sud Cardiovascular Institute

Massy, France

Location

Mulhouse Hospital

Mulhouse, 68000, France

Location

Pitié-Salpétrière Hospital

Paris, 75013, France

Location

Cochin Hospital

Paris, France

Location

Hôpital Haut-Lévèque

Pessac, 33604, France

Location

Hôpital Charles Nicolle

Rouen, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93207, France

Location

Toulouse University Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Myocardial InfarctionShock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Massimo Massetti, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Rémi Sabatier, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

June 1, 2005

Study Completion

October 1, 2009

Last Updated

August 2, 2010

Record last verified: 2010-07

Locations

FR(13)