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Not yet recruitingNCT07132489VaBiNoRUpdated Aug 29, 2025

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

An observational study in Myocardial Infarction and No Reflow Phenomenon, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
114
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Myocardial Infarction
  • No Reflow Phenomenon
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study will include patients presenting with ST-segment elevation myocardial infarction (STEMI) who are admitted to the [specify hospital/center] and undergo primary percutaneous coronary intervention (PCI).

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
114 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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.

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

  • 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.

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

Interventions

  • Diagnostic testHbA1c/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.

05

What researchers measure

Primary outcomes

  1. HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon

    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).

    Time frame: Baseline (prior to PCI)

  2. Albumin-bilirubin (ALBI) score predictive accuracy for no-reflow phenomenon

    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).

    Time frame: Baseline (prior to PCI)

  3. Neutrophil/HDL ratio predictive accuracy for no-reflow phenomenon

    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).

    Time frame: Baseline (prior to PCI)

Secondary outcomes

  1. Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with in-hospital major adverse cardiovascular events (MACE).

    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) \[unit: % of patients experiencing MACE\].

    Time frame: Baseline to hospital discharge.

  2. Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with 1-month major adverse cardiovascular events (MACE).

    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 \[unit: % of patients experiencing MACE\].

    Time frame: Baseline to 1-month follow-up.

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07132489
Lead sponsor
Assiut University
Responsible party
Hossam Eldin Alaa Abdelhafiz mohamed (Principal investigator, cardiology Department, Assiut University) — Principal investigator
First posted
Aug 20, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Aug 29, 2025

Study contacts

Hossam E. A. Abdelhafiz
Contact
Hossamalaa203040@gmail.com
00201143999651
Marwan S. Mahmoud
Contact
Hossam H. Ali
principal investigator
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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