Status:
NOT_YET_RECRUITING
Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI
Lead Sponsor:
Assiut University
Conditions:
STEMI
Diabete Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
ST-segment Elevation Myocardial Infarction (STEMI) remains a major cause of mortality despite the adoption of Primary Percutaneous Coronary Intervention (PPCI) as the standard treatment. However, outc...
Detailed Description
ST-segment Elevation Myocardial Infarction (STEMI) is a critical form of Acute Coronary Syndrome (ACS), resulting from abrupt plaque rupture and thrombotic coronary occlusion. Despite the widespread a...
Eligibility Criteria
Inclusion
- Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
- Managed with primary percutaneous coronary intervention (PPCI).
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07155395
Start Date
October 1 2025
End Date
April 1 2027
Last Update
September 4 2025
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