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 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT05350592
Eligibility Criteria:
Inclusion Criteria:
* Acute myocardial infarction
* Revascularization with PCI
* Presentation within 24 hours of chest pain
* ORBI risk score ≥ 10
* Age ≥ 18
Exclusion Criteria:
* Unwilling to give informed consent to study participation
* Unable to give consent due to language barrier
* Comatose after cardiac arrest
* Cardiogenic shock with systolic blood pressure \< 100 mmHg for more than 30 minutes or need for vasopressor to maintain blood pressure and arterial lactate \> 2,5 (2,0) mmol/L developed before leaving the cath. lab.
* Other major clinical non-coronary condition (stroke, sepsis etc.), which can explain a high ORBI risk score
* Referral for acute coronary artery bypass grafting (CABG) (\< 24 hours) after the CAG
* Contraindications against dobutamine infusion (sustained ventricular tachycardia prior to admission or noted in the cath.lab., known pheochromocytoma, idiopathic hypertrophic subaortic stenosis)
* Tocilizumab allergy
* Pregnant- or breastfeeding women
* Known liver disease/dysfunction
* Ongoing uncontrollable infection
* Immune deficiency/treatment with immunosuppressants
* Known, uncontrolled gastrointestinal (GI) disease predisposing to GI perforation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05350592
Study Brief:
Protocol Section:
NCT05350592