Actively Recruiting
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
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
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.
CONDITIONS
Official Title
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
Who Can Participate
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
Research Team
A
Alain COMBES, MD, PhD
CONTACT
G
Gilles MONTALESCOT, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here