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Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days). An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) * Revascularization by PCI for acute myocardial infarction has been performed or is planned in the following 60 minutes * Systolic blood pressure \<90 mmHg for \>30 min or catecholamine support required to maintain systolic blood pressure \>90 mmHg * Signs of pulmonary congestion * Signs of impaired organ perfusion with at least one of the following: Altered mental status OR cold, clammy skin and extremities OR oliguria with urine output \<30 ml/h OR serum lactate \>2.0 mmol/l Exclusion Criteria: * Age \<18 years * Pregnancy * Onset of shock \>24 Hours * Shock of other cause (hypovolemic, anaphylactic or vagal shock) * Shock due to massive pulmonary embolism * Resuscitation \>30 minutes * No intrinsic heart activity * Patient moribund on the day of randomization or SAPS II \>90 * Surgical revascularization for AMI (CABG) planned or already performed prior to randomization * Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology * Mechanical infarction complication (massive mitral regurgitation, pericardium drainage required, septal ventricular defect) * Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding ECMO and IABP insertion * Aortic regurgitation \> II * Other severe concomitant disease with limited life expectancy \< 1 year * Proven heparin-induced thrombocytopenia * ECMO device not immediately available
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What it tests

  • VA-ECMO
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Where

1 site
Hôpital Pitié Salpétrière
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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