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NCT07155395Not yet recruiting

Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI

Relationship Between Inflammatory and Hematological Indices and Coronary Artery Disease Severity and Outcome Among Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention

Source: ClinicalTrials.gov · Last updated 4 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
24 Aug 2025
Start date
1 Oct 2025
Primary completion date
31 Oct 2026
Lead sponsor
Assiut University
NCT number
NCT07155395

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Oct 2025 to the primary completion date, 31 Oct 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who underwent thrombolytic therapy or received anti-thrombotics prior to hospital arrival.
  • Prior coronary intervention: history of PCI or CABG.
  • 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).

Other illness

  • 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.

Lab values

  • 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).

Other

  • Patients not eligible for PPCI.
  • Recent blood transfusion within 3 months.

Who the study is looking for

  • Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
  • Managed with primary percutaneous coronary intervention (PPCI).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.