Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT04184635
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04184635
Study Brief:
Protocol Section:
NCT04184635