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ID04184635

Study of Early Use of VA-ECMO and IABP to Improve Survival in Adults With Acute Myocardial Infarction and Cardiogenic Shock

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-14

400

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether early use of venoarterial extracorporeal membrane oxygenation VA-ECMO combined with an intra-aortic balloon pump IABP can improve outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction AMI. This trial compares this combined approach to optimal medical treatment alone. Cardiogenic shock after AMI has a high mortality rate, often exceeding 40%, and VA-ECMO with IABP is being studied as a way to reduce this risk. Participants will be randomly assigned to one of two groups. The experimental group receives VA-ECMO support started as soon as possible, with IABP inserted in the opposite femoral artery, and management following a detailed protocol. For patients at centers without ECMO capability, a mobile ECMO team will initiate ECMO and transfer the patient to an ECMO center. The control group will receive standard medical care for cardiogenic shock according to current guidelines, without IABP or other temporary circulatory support devices, except for rescue VA-ECMO under specific severe conditions. During the study, participants will be monitored closely with assessments including survival, organ function, adverse cardiovascular events, bleeding, and heart function at 30 days and one year. The primary outcome is treatment failure at day 30. Researchers will also examine complications related to ECMO and quality of life measures. Consent is obtained from a relative or the patient when possible, and emergency consent procedures apply when needed. The study aims to provide evidence on whether early VA-ECMO plus IABP improves survival and organ support in this critical condition.

CONDITIONS

Brief Title

Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

Research Team

A

Alain COMBES, MD, PhD

G

Gilles MONTALESCOT, MD, PhD

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