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

Sponsor
Assiut University
Study ID
NCT07132489
Status
Not Yet Recruiting

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Conditions

  • Myocardial Infarction
  • No Reflow Phenomenon

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio — DIAGNOSTIC_TEST
    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.

Study Details

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

Key Dates

First listed
Aug 20, 2025
Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
114 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon [ Time Frame: Baseline (prior to PCI) ]

Central Contacts

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