Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04184635

Assessment of VA-ECMO and IABP in Acute Myocardial Infarction with Cardiogenic Shock to Prevent Organ Failure and Reduce Mortality

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

400

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

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) improves outcomes for patients who have acute myocardial infarction (heart attack) complicated by cardiogenic shock. Cardiogenic shock after a heart attack has a very high risk of death, around 40-50% within 30 days, and this trial aims to see if adding VA-ECMO and IABP to standard treatment can reduce this mortality rate. The study compares this combined treatment to optimal medical management alone, with an option to provide rescue VA-ECMO if needed for patients in the control group. Participants will be randomly assigned to one of two groups: the experimental group receives early VA-ECMO support plus IABP and standard medical care, while the control group receives standard medical care without IABP or other temporary circulatory support devices unless rescue VA-ECMO becomes necessary. VA-ECMO is initiated quickly, either onsite or by a mobile ECMO team if the patient is at a center without ECMO capability, with careful management and weaning protocols. IABP is inserted in the opposite femoral artery unless not possible. During the study, patients will be closely monitored for treatment failure at 30 days. Assessments include monitoring blood pressure, organ function, and signs of complications. Consent will be obtained from a close relative or surrogate before randomization, or from the patient when able. The study involves managing cardiogenic shock with standardized protocols and tracking outcomes to determine the potential benefit of early VA-ECMO plus IABP support over conventional treatment.

CONDITIONS

Official Title

Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Pitié Salpétrière

Paris, France, 75013

Actively Recruiting

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Research Team

A

Alain COMBES, MD, PhD

G

Gilles MONTALESCOT, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Authors/Task Force members, Stephan Windecker, Philippe Kolh...

https://pubmed.ncbi.nlm.nih.gov/25173339

Outcome after revascularisation of acute myocardial infarction with cardiogenic shock on extracorporeal life support.

Pavel Overtchouk, Julien Pascal, Guillaume Lebreton...

https://pubmed.ncbi.nlm.nih.gov/29400656

The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock.

Grégoire Muller, Erwan Flecher, Guillaume Lebreton...

https://pubmed.ncbi.nlm.nih.gov/26825953