Validation of New Biomarkers for Predicting No-Reflow in STEMI Patients Undergoing Primary PCI (VaBiNoR)

Assiut University

Status: Not yet enrolling

Conditions: No Reflow Phenomenon; Myocardial Infarction

Treatments: Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio

Study type: Observational

Funder types: Other

Identifiers

NCT07132489

New Biomarkers in No-Reflow

Details and patient eligibility

About

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

Full 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.

Enrollment: 114 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
• Provision of informed consent

Exclusion criteria

• 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

Trial design

114 participants in 2 patient groups

No-Reflow Group

Description:

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.

Treatment:

Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio

Reflow Group

Description:

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.

Treatment:

Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio