About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients presenting to Assiut University cardiac catheterization laboratory with ST-segment Elevation Myocardial Infarction (STEMI).
Managed with primary percutaneous coronary intervention (PPCI).
Disqualifiers
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.
Active infection or sepsis at admission (e.g., fever, leukocytosis, elevated CRP <100 mg/L without cardiac cause).
Trial population
Patients present with STEMI and undergoing primary percutaneous coronary intervention in Assiut university heart hospital (AUHH). Patients will be categorized into 2 groups: Diabetics and non-diabetics based on HbA1c.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite outcome including heart failure, fatal arrhythmia, death, re-infarction, stroke, and urgent target vessel revascularization. The prognostic value of various biomarkers (Hb/RDW, RDW/PDW, NAR, SII, SIRI) will be assessed in diabetic vs. non-diabetic STEMI patients during admission.
Angiographic outcomes including No Reflow Phenomenon
Assessment of angiographic outcomes following primary percutaneous coronary intervention (PPCI), with a specific focus on the incidence of the no-reflow phenomenon. No-reflow will be defined as inadequate myocardial perfusion in the absence of mechanical obstruction.
Secondary outcomes
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite outcome including heart failure, fatal arrhythmia, death, re-infarction, stroke, and urgent target vessel revascularization. The prognostic value of various biomarkers (Hb/RDW, RDW/PDW, NAR, SII, SIRI) will be assessed in diabetic vs. non-diabetic STEMI patients over the 6-month follow-up period.
Locations
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