Hpx•apoB Product as a Biomarker for Coronary Artery Disease

August 14, 2025 updated by: Qunxiong Fan, Shiyan City Renmin Hospital

The Hemopexin-Apolipoprotein B Product: A Novel Biomarker Integrating Oxidative Stress and Lipid Metabolism for Coronary Artery Disease Risk Stratification

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The pathophysiology of coronary artery disease (CAD) involves complex interactions between lipid dysregulation and oxidative stress. This study proposed and evaluated a novel composite biomarker, the Hemopexin-Apolipoprotein B (Hpx•apoB) product, which integrates a marker of atherogenic particle burden (apoB) with a marker reflecting the systemic response to heme-induced oxidative stress (Hpx). From January 2019 to December 2023, a total of 460 participants were enrolled: 350 patients with angiographically confirmed CAD (≥50% stenosis in a major coronary artery) and 110 control subjects without significant stenosis. Plasma Hpx was quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The study used multivariate logistic regression to assess the independent association between the Hpx•apoB product and CAD. Furthermore, its incremental diagnostic value was evaluated by calculating the area under the receiver operating characteristic curve (AUC), net reclassification improvement (NRI), and integrated discrimination improvement (IDI) when added to conventional risk factors and established risk scores (Framingham Risk Score and SCORE2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Renmin Hospital, Hubei University of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Coronary Artery Disease (CAD) Group (n=350)
Patients with angiographically confirmed stenosis of ≥50% in at least one major epicardial artery.
Procedure: Coronary Angiography
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).
Diagnostic test: Hpx•apoB Product Measurement
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)
Subjects who underwent coronary angiography for symptoms such as chest pain but were found to have no significant coronary stenosis (<50%).
Procedure: Coronary Angiography
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).
Diagnostic test: Hpx•apoB Product Measurement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product
Time Frame: Baseline
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)
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Hpx•apoB Product Concentration by Number of Diseased Vessels
Time Frame: Baseline
To assess the association with CAD severity, the mean plasma concentration of the Hpx•apoB product (Unit: mg²/L²) was compared across patient groups categorized by the number of diseased coronary vessels (one-, two-, or three-vessel disease), evaluated using a test for trend.
Baseline
Correlation Between Hpx•apoB Product and Gensini Score
Time Frame: Baseline
To assess the association with angiographic severity of CAD, the Spearman correlation coefficient was calculated between the plasma concentration of the Hpx•apoB product (Unit: mg²/L²) and the Gensini score. The Gensini score is a unitless index of atherosclerosis severity.
Baseline
Correlation Between Hpx•apoB Product and High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline
The Spearman correlation coefficient was calculated to assess the relationship between the plasma concentration of the Hpx•apoB product and hs-CRP (Unit: mg/L). The correlation coefficient is a unitless value.
Baseline
Correlation Between Hpx•apoB Product and Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline
The Spearman correlation coefficient was calculated to assess the relationship between the plasma concentration of the Hpx•apoB product and LDL-C (Unit: mmol/L). The correlation coefficient is a unitless value.
Baseline
Correlation Between Hpx•apoB Product and Triglycerides (TG)
Time Frame: Baseline
The Spearman correlation coefficient was calculated to assess the relationship between the plasma concentration of the Hpx•apoB product and triglycerides (Unit: mmol/L). The correlation coefficient is a unitless value.
Baseline
Correlation Between Hpx•apoB Product and Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline
The Spearman correlation coefficient was calculated to assess the relationship between the plasma concentration of the Hpx•apoB product and eGFR (Unit: mL/min/1.73m²). The correlation coefficient is a unitless value.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiyan City Renmin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • syrmyy2018-079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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