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The study was stopped prematurely due to insufficient recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | IABP, inotropic drugs, antiplatelet agents according to site habits. | |
| Experimental | Experimental | ECLS +/- IABP, inotropic drugs, antiplatelet agents according to site habits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-Corporeal Life Support -Impella 2.5 | Device | Percutaneous implantation of Impella pump for a duration of 3 days as a minimum and up to 7 days (recommended) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of BNP levels between H0 and H24 (Ho is defined as the nearest value of BNP level before the randomization). | one month |
| Measure | Description | Time Frame |
|---|---|---|
| BNP levels measured at H6, H12, H48 and H72. | one month | |
| BNP level measured at H48 after assistance weaning. | one month | |
| haemoglobin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Massetti, MD | University Hospital, Caen | Principal Investigator |
| Rémi Sabatier, MD | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Brest | 29000 | France | |||
| Caen University Hospital |
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|
| one month |
| lactate levels | one month |
| creatinine levels | 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. | one month |
| Mortality at Day 30, at 6 months, at 1 year. | one year |
| Infarct size at 1 month and 4 months. | 4 months |
| Amines maximal dose | one month |
| Cardiologic treatments outside the hospital | one year |
| Assistance last | one month |
| mechanical ventilation last | one month |
| assistance weaning failure | one month |
| haemorrhagic, ischemic and septic complications. | six months |
| Caen |
| 14000 |
| France |
| Clermont-Ferrand University Hospital | Clermont-Ferrand | 63000 | France |
| Hôpital de la Croix Rousse | Lyon | 69317 | France |
| Hôpital de la Timone | Marseille | 13008 | France |
| Paris Sud Cardiovascular Institute | Massy | France |
| Mulhouse Hospital | Mulhouse | 68000 | France |
| Pitié-Salpétrière Hospital | Paris | 75013 | France |
| Cochin Hospital | Paris | France |
| Hôpital Haut-Lévèque | Pessac | 33604 | France |
| Hôpital Charles Nicolle | Rouen | France |
| Centre Cardiologique du Nord | Saint-Denis | 93207 | France |
| Toulouse University Hospital | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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