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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT06475456
Eligibility Criteria:
Inclusion Criteria:
All subjects participating in this clinical trial must meet the following criteria:
Prospective cohort
* For conscious patients, signed and dated informed consent and consent to the processing of personal data
* For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18
CS will be defined as:
1. Systolic blood pressure (SBP) \<90 mmHg or mean arterial pressure (MAP) \<60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg, OR need of MCS;
2. At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \<60%; arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
3. CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)
Exclusion Criteria:
Patients will be excluded if any of the following conditions apply:
1. Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20')
2. Absolute contraindication to support devices.
3. CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning.
4. Age greater than 75-year-old
5. Life expectancy \< 1 year due to other reason than cardiogenic shock.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06475456
Study Brief:
Protocol Section:
NCT06475456