Validation of New Biomarkers for Predicting No-Reflow in STEMI Patients Undergoing Primary PCI
NCT ID: NCT07132489
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
114 participants
OBSERVATIONAL
2025-09-01
2028-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
HbA1c/C-peptide ratio
Albumin-bilirubin (ALBI) score.
Neutrophil/HDL ratio
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Value of Heart-Fatty Acid Binding Protein and Ischemia Modified Albumin as Biochemical Markers on Non ST Segment Elevation Acute Coronary Syndrome at the Emergency Room.
NCT00714298
Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI
NCT06123793
Association Between Peri-procedural Myocardial Injury and Quantitative Blood Flow Ratio
NCT07110298
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.
NCT00769574
Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.
NCT04785209
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recent research has identified several novel biomarkers that may help predict the risk of no-reflow. These include metabolic, inflammatory, and hepatic-renal markers that reflect the systemic milieu of patients with acute coronary syndromes. Among these emerging biomarkers, the following are of particular interest:
* HbA1c/C-peptide ratio: Reflects chronic glycemic burden and residual beta-cell function.
* Neutrophil/HDL ratio: A combined marker of inflammation and lipid-associated atheroprotection.
* Albumin-bilirubin (ALBI) score: A composite liver function marker potentially linked to systemic inflammation and perfusion status.
This study aims to validate the prognostic value of these biomarkers in predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI.
To validate the clinical utility of selected emerging biomarkers in predicting the no-reflow phenomenon among patients presenting with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
Thus , our objective is to investigate :
1. To investigate whether the HbA1c to C-peptide ratio can serve as a predictive marker for no-reflow, reflecting the impact of chronic glycemic control and pancreatic beta-cell function.
2. To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
3. To examine the prognostic value of the albumin-bilirubin (ALBI) score in identifying patients at higher risk for no-reflow, considering the systemic influence of hepatic function and inflammation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No-Reflow Group
STEMI patients undergoing primary PCI who develop angiographic no-reflow, defined as final TIMI flow ≤2 and/or Myocardial Blush Grade (MBG) 0-1 after stent deployment in the absence of mechanical obstruction (no dissection, spasm, residual thrombus, or significant residual stenosis). Planned enrollment: 56.
HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio
1. To investigate whether the HbA1c to C-peptide ratio can serve as a predictive marker for no-reflow, reflecting the impact of chronic glycemic control and pancreatic beta-cell function.
2. To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
3. To examine the prognostic value of the albumin-bilirubin (ALBI) score in identifying patients at higher risk for no-reflow, considering the systemic influence of hepatic function and inflammation.
Reflow Group
STEMI patients undergoing primary PCI who achieve successful epicardial and microvascular reperfusion, defined as final TIMI 3 flow and MBG 2-3 after PCI. Planned enrollment: 56.
HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio
1. To investigate whether the HbA1c to C-peptide ratio can serve as a predictive marker for no-reflow, reflecting the impact of chronic glycemic control and pancreatic beta-cell function.
2. To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
3. To examine the prognostic value of the albumin-bilirubin (ALBI) score in identifying patients at higher risk for no-reflow, considering the systemic influence of hepatic function and inflammation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio
1. To investigate whether the HbA1c to C-peptide ratio can serve as a predictive marker for no-reflow, reflecting the impact of chronic glycemic control and pancreatic beta-cell function.
2. To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
3. To examine the prognostic value of the albumin-bilirubin (ALBI) score in identifying patients at higher risk for no-reflow, considering the systemic influence of hepatic function and inflammation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
* Provision of informed consent
Exclusion Criteria
* Known chronic inflammatory or autoimmune diseases
* Advanced renal or hepatic failure
* Active infection or malignancy at presentation
* Incomplete data or refusal to consent
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hossam Eldin Alaa Abdelhafiz mohamed
Principal investigator, cardiology Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hossam H. Ali
Role: PRINCIPAL_INVESTIGATOR
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Marwan S. Mahmoud
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
New Biomarkers in No-Reflow
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.