Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
Recruiting · NCT04184635 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
VA-ECMO
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Hôpital Pitié Salpétrière - Paris, France