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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02219802
Eligibility Criteria:
Inclusion Criteria:
* Acute myocardial infarction eligible for primary PCI:
* \> 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography)
* Reperfusion is expected to be feasible within 12 hours after onset of complaints
* Infarct related artery eligible for PPCI and:
* De novo lesion in a native coronary artery
* Reference-vessel diameter ≥ 2.5mm and ≤ 4mm
* Without severe calcification
* Without diameter stenosis of \>50% (by visual assessment) after thrombus aspiration and pre-dilatation.
The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.
Exclusion Criteria:
* Age \< 18 years and \> 75 years
* History of myocardial infarction
* Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor.
* Participation in another clinical study, interfering with this protocol
* Uncertain neurological outcome e.g. resuscitation
* Intubation/ventilation
* Cardiogenic shock prior to randomization
* Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA \< 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)
* Gastro-intestinal / urinary tract bleeding \< 2 months prior to inclusion
* Refusal to receive blood transfusion
* Planned major surgery within 6 weeks
* Stent implantation \< 1 month prior to inclusion
* Expected mortality from any cause within the next 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02219802
Study Brief:
Protocol Section:
NCT02219802