Hpx•apoB Product as a Biomarker for Coronary Artery Disease

NCT07126132 | Completed

• 1 other identifier: syrmyy2018-079
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-center, cross-sectional study designed to investigate a novel composite biomarker, the Hemopexin-Apolipoprotein B (Hpx•apoB) product, for its association with coronary artery disease (CAD). The study aimed to determine if the Hpx•apoB product could serve as an independent predictor for the presence and severity of CAD and to evaluate its incremental value in improving risk stratification when added to existing clinical risk models.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product

  This outcome assesses the strength of association between the biomarker and CAD. The plasma concentration of the Hpx•apoB product (Unit: mg²/L²) was used as a continuous variable in a multivariable logistic regression model to predict the presence of CAD. The result is expressed as an Odds Ratio (OR), a unitless measure, with a 95% confidence interval.

  Baseline

• Change in Area Under the Receiver Operating Characteristic Curve (AUC)

  This outcome measures the incremental predictive value of the Hpx•apoB product. The AUC of a baseline risk model (containing hs-CRP and LDL-C) was compared to the AUC of the same model with the Hpx•apoB product added. The change in AUC (ΔAUC) quantifies the improvement in model discrimination. AUC is a unitless value ranging from 0.5 to 1.0.

  Baseline

Secondary Outcomes (6)

• Comparison of Hpx•apoB Product Concentration by Number of Diseased Vessels

  Baseline

• Correlation Between Hpx•apoB Product and Gensini Score

  Baseline

• Correlation Between Hpx•apoB Product and High-Sensitivity C-Reactive Protein (hs-CRP)

  Baseline

• Correlation Between Hpx•apoB Product and Low-Density Lipoprotein Cholesterol (LDL-C)

  Baseline

• Correlation Between Hpx•apoB Product and Triglycerides (TG)

  Baseline

Study Arms (2)

Coronary Artery Disease (CAD) Group (n=350)

Patients with angiographically confirmed stenosis of ≥50% in at least one major epicardial artery.

Procedure: Coronary Angiography; Diagnostic Test: Hpx•apoB Product Measurement

Control Group (n=110)

Subjects who underwent coronary angiography for symptoms such as chest pain but were found to have no significant coronary stenosis (\<50%).

Procedure: Coronary Angiography; Diagnostic Test: Hpx•apoB Product Measurement

Interventions

Coronary Angiography PROCEDURE

Standard coronary angiography was performed via the radial or femoral approach on all participants to assess the presence and severity of coronary artery disease. Angiograms were used to determine coronary stenosis, which formed the basis for classifying participants into the CAD group (≥50% stenosis) or the control group (\<50% stenosis).

Control Group (n=110); Coronary Artery Disease (CAD) Group (n=350)

Hpx•apoB Product Measurement DIAGNOSTIC_TEST

Fasting blood samples were collected from all participants to measure the novel Hpx•apoB product. Plasma hemopexin (Hpx) was quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and apolipoprotein B (apoB) was measured using standard automated methods. This biomarker was the primary variable of interest for its association with CAD.

Control Group (n=110); Coronary Artery Disease (CAD) Group (n=350)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of consecutive patients aged 18 years or older who were referred for coronary angiography at the Department of Cardiovascular Medicine, Renmin Hospital, Hubei University of Medicine, due to suspected or known coronary artery disease (CAD). From this population, 460 participants were enrolled after applying inclusion and exclusion criteria. Participants were then allocated into a CAD group (n=350) or a control group (n=110) based on angiographic findings.

You may qualify if:

• Aged ≥18 years.
• Referred for coronary angiography due to suspected or known CAD.
• Provided written informed consent.

You may not qualify if:

• Acute infectious or systemic inflammatory diseases.
• Severe hepatic or renal dysfunction (eGFR \< 30 mL/min/1.73m²).
• Malignancy.
• Autoimmune disease.
• A history of major surgery within the past three months.

Sponsors & Collaborators

• Shiyan City Renmin Hospital: lead

Study Sites (1)

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood samples were collected into EDTA-containing tubes. Plasma was separated and used to measure hemopexin (Hpx), apolipoprotein B (apoB), lipid profile, hs-CRP, and other standard laboratory parameters.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (1)