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Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
RECRUITINGN/ASponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
PhaseN/A
SponsorAssistance Publique - Hôpitaux de Paris
Started2021-10-14
Est. completion2026-10-14
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04184635
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
Acute Myocardial InfarctionCardiogenic ShockHeart Disease
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Actively Recruiting
PhaseN/A
SponsorAssistance Publique - Hôpitaux de Paris
Started2021-10-14
Est. completion2026-10-14
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04184635