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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT07155395
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
* Managed with primary percutaneous coronary intervention (PPCI).
Exclusion Criteria:
* Patients not eligible for PPCI.
* Patients who underwent thrombolytic therapy or received anti-thrombotics prior to hospital arrival.
* Prior coronary intervention: history of PCI or CABG.
* Known hematological disorders:
Thalassemia (microcytic anemia, normal iron profile, HbA2 ≥ 3.5% or elevated HbF).
Myelodysplastic syndromes (unexplained cytopenias with ≥10% dysplasia in bone marrow aspirate).
Leukemia (persistent leukocytosis or pancytopenia, blasts ≥20% in peripheral blood).
* Active infection or sepsis at admission (e.g., fever, leukocytosis, elevated CRP \<100 mg/L without cardiac cause).
* Known autoimmune or chronic inflammatory diseases (e.g., systemic lupus erythematosus).
* Known or newly diagnosed malignancy.
* End-stage renal disease (eGFR \<30 ml/min/1.73 m² or on dialysis).
* Advanced hepatic impairment (Child-Pugh class C; bilirubin \>3 mg/dL or ALT/AST \>3× upper limit of normal).
* Recent blood transfusion within 3 months.
* Recent use of steroids, chemotherapy, or immunosuppressive drugs.
* Mechanical complications or cardiogenic shock prior to or during STEMI presentation (e.g., papillary muscle rupture, ventricular septal defect, need for intra-aortic balloon pump).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07155395
Study Brief:
Protocol Section:
NCT07155395