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

ConditionsMyocardial InfarctionNo Reflow Phenomenon
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Suitable for and undergoing timely primary PCI based on symptoms and clinical judgment

Provision of informed consent

Disqualifiers

History of previous MI, PCI, or CABG

Known chronic inflammatory or autoimmune diseases

Advanced renal or hepatic failure

Active infection or malignancy at presentation

Trial 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).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: No-Reflow Group1 intervention
Group B: Reflow Group1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: