Validation of New Biomarkers for Predicting No-Reflow in STEMI Patients Undergoing Primary PCI
- Conditions
- Myocardial InfarctionNo Reflow Phenomenon
- Registration Number
- NCT07132489
- Lead Sponsor
- Assiut University
- Brief Summary
To evaluate the diagnostic value of the selected emerging biomarkers in predicting the no-reflow phenomenon among patients presenting with STEMI undergoing primary PCI. These biomarkers include:
HbA1c/C-peptide ratio
Albumin-bilirubin (ALBI) score.
Neutrophil/HDL ratio
- Detailed Description
The no-reflow phenomenon is a well-recognized complication following primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). Despite successful opening of the occluded coronary artery, impaired myocardial perfusion may persist, significantly increasing the risk of adverse cardiovascular outcomes.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- Age ≥ 18 years
- Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
- Provision of informed consent
- History of previous MI, PCI, or CABG
- Known chronic inflammatory or autoimmune diseases
- Advanced renal or hepatic failure
- Active infection or malignancy at presentation
- Incomplete data or refusal to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon Baseline (prior to PCI) Diagnostic accuracy of HbA1c/C-peptide ratio for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).
Neutrophil/HDL ratio predictive accuracy for no-reflow phenomenon Baseline (prior to PCI) Diagnostic accuracy of neutrophil/HDL ratio for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).
Albumin-bilirubin (ALBI) score predictive accuracy for no-reflow phenomenon Baseline (prior to PCI) Diagnostic accuracy of ALBI score for predicting the no-reflow phenomenon in STEMI patients undergoing primary PCI, assessed by area under the ROC curve (AUC).
- Secondary Outcome Measures
Name Time Method Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with in-hospital major adverse cardiovascular events (MACE). Baseline to hospital discharge. HbA1c/C-peptide ratio (unit: ratio, measured from immunoassay-derived HbA1c and C-peptide levels), Neutrophil-to-HDL ratio (unit: ratio, derived from complete blood count and serum HDL measurement), and Albumin-Bilirubin (ALBI) score (unit: score, calculated from serum albumin \[g/dL\] and total bilirubin \[mg/dL\]) will be correlated with the incidence of in-hospital major adverse cardiovascular events (MACE) \[unit: % of patients experiencing MACE\].
Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with 1-month major adverse cardiovascular events (MACE). Baseline to 1-month follow-up. HbA1c/C-peptide ratio (unit: ratio, measured from immunoassay-derived HbA1c and C-peptide levels), Neutrophil-to-HDL ratio (unit: ratio, derived from complete blood count and serum HDL measurement), and Albumin-Bilirubin (ALBI) score (unit: score, calculated from serum albumin \[g/dL\] and total bilirubin \[mg/dL\]) will be correlated with the incidence of major adverse cardiovascular events (MACE) at 1-month follow-up \[unit: % of patients experiencing MACE\].