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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT05728359
Eligibility Criteria:
Inclusion Criteria:
* All of the following are required for inclusion following screening:
* Willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee
* Presentation within 24 hours of onset of ACS symptoms.
* CS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or myocarditis
* Planned or completed revascularisation of culprit coronary artery
CS will be defined by:
* Systolic blood pressure \<90 mmHg for at least 30 minutes
* A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure \> 90 mmHg.
* Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:
* altered mental status.
* cold and clammy skin and limbs.
* oliguria with a urine output of less than 30 ml per hour.
* elevated arterial lactate level of \>2.0 mmol per litre.
Exclusion Criteria:
* Any of the inclusion criteria not met and:
1. Unwilling to provide informed consent.
2. Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation.
3. Age \<18 and ≥80 years.
4. Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
5. Significant systemic illness
6. Known dementia of any severity
7. Comorbidity with life expectancy \<12 months.
8. Out-of-hospital cardiac arrest (OHCA) and any of the following:
1. No return of spontaneous circulation (ongoing resuscitation effort)
2. pH \<7
3. Without bystander CPR within 10 minutes of collapse
9. Arterial lactate level of \<2.0 mmol per litre.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05728359
Study Brief:
Protocol Section:
NCT05728359