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:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03637205
Eligibility Criteria:
Inclusion Criteria:
* Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
* Planned revascularization (PCI or alternatively CABG)
* Systolic blood pressure \<90 mmHg \>30 min or catecholamines required to maintain pressure \>90 mmHg during Systole
* Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output \<30 ml/h
* Arterial lactate \>3 mmol/l
* Informed consent
Exclusion Criteria:
* Resuscitation \>45 minutes
* Mechanical cause of cardiogenic shock
* Onset of shock \>12 h
* Severe peripheral artery disease with impossibility to insert ECLS cannulae
* Age \<18 years or age \>75 years
* Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
* Other severe concomitant disease with limited life expectancy \<6 months
* Pregnancy
* Participation in another trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03637205
Study Brief:
Protocol Section:
NCT03637205