Using VA-ECMO to treat cardiogenic shock in heart attack patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with intra-aortic balloon pump (IABP) support in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI). It aims to determine if this combination improves patient outcomes compared to optimal medical treatment alone. Patients will be closely monitored, and those who do not respond to conventional treatment will have access to VA-ECMO as a rescue option. The study is designed to provide critical data on the potential benefits of early intervention in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Pitié Salpétrière
  Paris, France Recruiting

Study contacts

• Principal investigator: Alain COMBES, MD, PhD — Centre Hospitalier Universitaire Pitié-Salpêtrière Paris
• Study coordinator: Alain COMBES, MD, PhD
• Email: alain.combes@aphp.fr
• Phone: 01.42.16.38.16

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• Registry of patients with acute cardiovascular disease in a cardiac intensive care unit

  This study is looking at patients with serious heart conditions in the Cardiac Intensive Care Unit to see how they do during and after their hospital stay.

  Recruiting University Hospital, Ioannina · Ioannina, Epirus · NCT06081205

• Comparing revascularization strategies for heart attack patients with cardiogenic shock

  This study is testing whether treating multiple blocked heart arteries right away helps heart attack patients in shock feel better compared to just fixing the main blockage.

  Recruiting Phase 4 Samsung Medical Center · Seoul · NCT05527717

• Collaborative effort to improve care for patients with cardiogenic shock

  This study is trying to gather information on how to better care for patients with cardiogenic shock caused by heart problems to help improve their treatment and outcomes.

  Recruiting at 3 sites University of Utah · Weston, Florida and 2 other locations · NCT05185492

• Factors Influencing Outcomes in ECMO and Impella Patients

  This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.

  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

  This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07769528

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.