Inflammatory and Hematological Indices in Diabetic STEMI Patients Undergoing Primary PCI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Diabetic STEMI Patients
Group B: Non-Diabetic STEMI Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
Peri-procedural
2

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.

Time frame
At time of Primary PCI (within 24 hours of admission)

Secondary outcomes

1

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.

Time frame
Up to 6 months post-PCI

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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