Using VA-ECMO to treat cardiogenic shock in heart attack patients
Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
This study is testing if using a special heart support machine along with another device can help heart attack patients in severe shock feel better compared to just standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04184635 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing cardiogenic shock due to acute myocardial infarction who require immediate revascularization.
Not a fit: Patients with shock from causes other than acute myocardial infarction or those who are moribund at the time of randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in patients suffering from cardiogenic shock due to heart attacks.
How similar studies have performed: While the use of VA-ECMO in this context is gaining traction, high-level evidence is still lacking, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.