Not Yet RecruitingNot Applicable

Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI

1,000 participantsStarted 2025-10

Plain-language 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, outcomes still vary significantly among patients, especially between diabetic and non-diabetic cohorts. The research question driving this study is: Can hematologic, inflammatory, and thrombotic indices serve as reliable prognostic tools in predicting the no-reflow phenomenon and coronary artery disease (CAD) severity in STEMI patients, particularly among those with diabetes mellitus? Recent literature identifies inflammation as a key contributor to the pathogenesis and outcomes of Acute Coronary Syndrome (ACS), including the no-reflow phenomenon and Major Adverse Cardiovascular Events (MACE). Markers such as C-reactive protein (CRP), Neutrophil-to-Albumin Ratio (NAR), Red Cell Distribution Width (RDW), Platelet Distribution Width (PDW), Hemoglobin-to-Red Cell Distribution Width ratio (Hb/RDW), and the RDW/PDW ratio have shown individual correlations with poor outcomes. Emerging indices such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammatory Response Index (SIRI) further integrate immune and inflammatory components and have shown promise in early risk stratification. The current strategy in many cardiac centers relies on angiographic and clinical indicators, which may be insufficient for individualized risk prediction. Hence, incorporating accessible and cost-effective blood-based markers could significantly enhance prognostic accuracy. The rationale of this research lies in comparing these indices in diabetic versus non-diabetic STEMI patients, aiming to stratify risk, predict no-reflow, assess coronary artery disease burden using the SYNTAX score, and identify those at risk for early adverse outcomes.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Incidence of Major Adverse Cardiovascular Events (MACE)

Timeframe: Peri-procedural

Angiographic outcomes including No Reflow Phenomenon

Timeframe: At time of Primary PCI (within 24 hours of admission)

Trial details

NCT IDNCT07155395

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

David Emil Efraim

+201091620534 David.17289572@med.aun.edu.eg