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Clinical Trials in France / NCT04184635
Recruiting Not applicable

Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

NCT04184635 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-10-14
Last updated
2025-01-14

Condition(s) studied

Acute Myocardial InfarctionCardiogenic Shock

Investigational drug(s) / intervention(s)

VA-ECMO

VA-ECMO: * The ECMO device will be the CardioHelp (MAQUET, GETINGE, Orléans, France) using the veno-arterial setting and percutaneous femoro-femoral cannulation with MAQUET GETINGE HLS cannulae. * Intraortic balloon pump will be MEGA 50 cc or 40cc, (MAQUET, GETINGE, Orléans, France).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié Salpétrière Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04184635 on ClinicalTrials.gov ↗ ← All trials in France