Integrated AssessmentNCT07890168
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
An observational study of Integrated Assessment and Immune-Inflammatory, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Integrated Assessment, Immune-Inflammatory, Metabolic Biomarkers
- What is being tested?
- Assessment of immune-inflammatory and metabolic biomarkers
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective multi-center observational cohort study will be conducted in the Cardiology Department on 400 patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82511
Remon S Adly, MD, 00201221878986, remonsaleh@yahoo.com
About this study
Official title: Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients; A Prospective Cohort Study
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.
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) remains one of the leading causes of morbidity and mortality worldwide, accounting for a substantial proportion of deaths related to ischemic heart disease.
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for STEMI, as it restores epicardial coronary blood flow and significantly reduces mortality compared with thrombolytic therapy.
In recent years, composite immune-inflammatory indices such as the Systemic Immune-Inflammation Index (SII) have emerged as simple and reproducible markers reflecting the balance between inflammation and immune response. In parallel, metabolic indices such as the Triglyceride-Glucose (TyG) index and the uric acid-to-HDL cholesterol ratio (UHR) have been proposed as surrogate markers of insulin resistance, oxidative stress, and endothelial dysfunction-all of which contribute to microvascular injury.
- Conditions
- Integrated Assessment, Immune-Inflammatory, Metabolic Biomarkers, Coronary No-Reflow, Primary Percutaneous Coronary Intervention, ST Segment Elevation Myocardial Infarction
- Being tested
- Assessment of immune-inflammatory and metabolic biomarkers
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of immune-inflammatory and metabolic biomarkersDiagnostic 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 | Role | What they receive |
|---|---|---|
| Study group | Patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) Receives: Diagnostic Test: Assessment of immune-inflammatory and metabolic biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the primary percutaneous coronary intervention (Day 1).
Secondary outcomes (8)
Occurrence of coronary no-reflow following primary percutaneous coronary intervention
Percentage of participants with coronary no-reflow, defined as final thrombolysis in myocardial infarction (TIMI) flow grade <3 and/or myocardial blush grade ≤1 at the end of primary percutaneous coronary intervention (PCI), in the absence of mechanical obstruction such as dissection, residual stenosis, or spasm.
Measured: Day 1, immediately at the end of primary percutaneous coronary intervention
Predictive performance of the Triglyceride-Glucose index for coronary no-reflow
Area under the receiver operating characteristic (ROC) curve for admission triglyceride-glucose (TyG) index in predicting coronary no-reflow following primary percutaneous coronary intervention (PCI). TyG is calculated as ln [triglycerides (mg/dL) × fasting glucose (mg/dL) / 2]
Measured: Day 1, at the end of percutaneous coronary intervention
Predictive performance of the uric acid-to-HDL cholesterol ratio (UHR) for coronary no-reflow
Area under the ROC curve for admission uric acid-to-HDL cholesterol ratio (UHR) in predicting coronary no-reflow following primary percutaneous coronary intervention (PCI). UHR is calculated as serum uric acid divided by HDL cholesterol.
Measured: Day 1, at the end of percutaneous coronary intervention
Occurrence of in-hospital heart failure
ercentage of participants who develop heart failure during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Measured: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital malignant arrhythmias
Percentage of participants who experience malignant arrhythmias during the index hospitalization. Their association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Measured: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital cardiogenic shock
Percentage of participants who develop cardiogenic shock during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Measured: Until discharge or death during the index hospitalization (up to 30 days)
Occurrence of in-hospital reinfarction
Percentage of participants who experience reinfarction during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Measured: Until discharge or death during the index hospitalization (up to 30 days)
All-cause in-hospital mortality
Percentage of participants who die from any cause during the index hospitalization. Its association with admission immune-inflammatory and metabolic biomarkers will be evaluated.
Measured: Until discharge or death during the index hospitalization (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Sep 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrated AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remon Saleh Adly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890168
- Sponsor's protocol ID
- 20260930016
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.