Myocardial InfarctionVaBiNoRNCT07132489
Validation of New Biomarkers for Predicting No-Reflow in STEMI Patients Undergoing Primary PCI
An observational study of Myocardial Infarction and No Reflow Phenomenon, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, No Reflow Phenomenon
- What is being tested?
- HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- Age ≥ 18 years
- Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
- Provision of informed consent
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marwan S. Mahmoud contact
About this study
Official title: Validation of Novel Metabolic, Inflammatory, and Hepatic-Renal Biomarkers-HbA1c/C-peptide Ratio, Neutrophil/HDL Ratio, and ALBI Score-for Predicting the No-Reflow Phenomenon After Primary PCI in Patients With STEMI.
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 :
- 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.
- To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
- 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
- Myocardial Infarction, No Reflow Phenomenon
- Being tested
- HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio
- Medical subject headings
- Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratioDiagnostic test
- 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.
- To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (prior to PCI)
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).
Measured: Baseline (prior to PCI)
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).
Measured: Baseline (prior to PCI)
Secondary outcomes (2)
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].
Measured: Baseline to hospital discharge.
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].
Measured: Baseline to 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldin Alaa Abdelhafiz mohamed, Assiut University
- Investigators
- Hossam H. Ali, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132489
- Sponsor's protocol ID
- New Biomarkers in No-Reflow
- Acronym
- VaBiNoR
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Novel Metabolic, Inflammatory, and Hepatic-Renal Biomarkers-HbA1c/C-peptide Ratio, Neutrophil/HDL Ratio, and ALBI Score-for Predicting the No-Reflow Phenomenon After Primary PCI in Patients With STEMI.
- ClinicalTrials.gov ID
- NCT07132489
- Acronym / sponsor ID
- VaBiNoR / New Biomarkers in No-Reflow
- Conditions
- Myocardial Infarction, No Reflow Phenomenon
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
- To evaluate the neutrophil-to-HDL ratio as a potential indicator of no-reflow, representing the balance between systemic inflammation and endogenous vascular protection.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Reflow Group | – | Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratioSTEMI 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. |
| Reflow Group | – | Diagnostic Test: HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratioSTEMI 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment
- Provision of informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratio1. 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. | Diagnostic test | No-Reflow Group, Reflow Group |
Primary outcome
HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon
Time frame: 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).
Albumin-bilirubin (ALBI) score predictive accuracy for no-reflow phenomenon
Time frame: 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).
Neutrophil/HDL ratio predictive accuracy for no-reflow phenomenon
Time frame: 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).
2 secondary outcomes
Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with in-hospital major adverse cardiovascular events (MACE).
Time frame: Baseline to hospital discharge.
Correlation of HbA1c/C-peptide ratio, Neutrophil-to-HDL ratio, and Albumin-Bilirubin (ALBI) score with 1-month major adverse cardiovascular events (MACE).
Time frame: Baseline to 1-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marwan S. Mahmoud contact
Hossam H. Ali principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and No Reflow Phenomenon, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam E. A. Abdelhafiz (00201143999651, Hossamalaa203040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c/C-peptide ratio predictive accuracy for no-reflow phenomenon (time frame: Baseline (prior to PCI)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.