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 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT01472718
Eligibility Criteria:
Inclusion Criteria:
1. Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2 contiguous ECG leads, or new left bundle branch block (LBBB)
2. Presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter)
3. Written informed consent
Exclusion Criteria:
* Low-risk (ST elevation in ≤2 leads) inferior AMI
* Previous infarction in the same area (assessed by ECG)
* PCI in the 2 weeks prior to AMI
* Active internal bleeding
* History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit
* Head or spine surgery or trauma in the previous 2 months
* Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
* Administration of oral anticoagulants within seven days unless prothrombin time is \<1.2 times control
* Bleeding diathesis or severe uncontrolled arterial hypertension
* Thrombocytopenia (\<100 000 cells/mL)
* Recent (within six weeks) major surgery or trauma
* Intracranial neoplasm, arteriovenous malformation, or aneurysm
* Severe renal or liver failure
* Allergy to aspirin
* Contraindication to MRI examination
* Pregnancy and lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01472718
Study Brief:
Protocol Section:
NCT01472718