NCT07132489

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Sep 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

August 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 11, 2025

Last Update Submit

August 25, 2025

Conditions

Myocardial InfarctionNo Reflow Phenomenon

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    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).

    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).

    Baseline to 1-month follow-up.

Study Arms (2)

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

HbA1c/C-peptide ratio Albumin-bilirubin (ALBI) score. Neutrophil/HDL ratioDIAGNOSTIC_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.

No-Reflow GroupReflow Group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial InfarctionNo-Reflow Phenomenon

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hossam H. Ali

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossam E. A. Abdelhafiz

CONTACT

00201143999651Hossamalaa203040@gmail.com

Marwan S. Mahmoud

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, cardiology Department

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 20, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 29, 2025

Record last verified: 2025-08