Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients

NCT07890168 | Recruiting

• 1 other identifier: 20260930016
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the combined predictive value of immune-inflammatory and metabolic biomarkers for coronary no-reflow following primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), with the goal of improving early risk stratification and clinical decision-making.

Conditions

Integrated Assessment; Immune-Inflammatory; Metabolic Biomarkers; Coronary No-Reflow; Primary Percutaneous Coronary Intervention; ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Predictive performance of the Systemic Immune-Inflammation Index (SII) for coronary no-reflow

  Predictive performance of admission Systemic Immune-Inflammation Index (SII), calculated as platelet count × neutrophil count / lymphocyte count, for coronary no-reflow following primary percutaneous coronary intervention (PCI), assessed using the area under the receiver operating characteristic (ROC) curve.

  During the primary percutaneous coronary intervention (Day 1).

Secondary Outcomes (8)

• Occurrence of coronary no-reflow following primary percutaneous coronary intervention

  Day 1, immediately at the end of primary percutaneous coronary intervention

• Predictive performance of the Triglyceride-Glucose index for coronary no-reflow

  Day 1, at the end of percutaneous coronary intervention

• Predictive performance of the uric acid-to-HDL cholesterol ratio (UHR) for coronary no-reflow

  Day 1, at the end of percutaneous coronary intervention

• Occurrence of in-hospital heart failure

  Until discharge or death during the index hospitalization (up to 30 days)

• Occurrence of in-hospital malignant arrhythmias

  Until discharge or death during the index hospitalization (up to 30 days)

Study Arms (1)

Study group

Patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)

Diagnostic Test: Assessment of immune-inflammatory and metabolic biomarkers

Interventions

Assessment of immune-inflammatory and metabolic biomarkers DIAGNOSTIC_TEST

Venous blood samples will be collected on admission before primary percutaneous coronary intervention for complete blood count and biochemical analysis. Laboratory results will be used to calculate the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), Systemic Inflammatory Response Index (SIRI), Triglyceride-Glucose (TyG) index, and uric acid-to-HDL cholesterol ratio (UHR).

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective multi-center observational cohort study will be conducted in the Cardiology Department on 400 patients.

You may qualify if:

• Age ≥18 years old.
• Both sexes.
• Diagnosis of ST-segment elevation myocardial infarction (STEMI) according to current ESC/ACC guidelines.
• Presentation within 12 hours of symptom onset.
• Undergoing primary percutaneous coronary intervention (PCI) as the reperfusion strategy.

You may not qualify if:

• Active infection or sepsis.
• Chronic inflammatory or autoimmune diseases.
• Hematological disorders.
• Active malignancy.
• Severe liver disease.
• End-stage renal disease requires dialysis.
• Previous coronary artery bypass graft surgery (CABG).
• Current use of chronic corticosteroid or immunosuppressive therapy.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Remon S Adly, MD

CONTACT

00201221878986; remonsaleh@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiovascular, Faculty of Medicine, Sohag University, Sohag, Egypt.

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)