Hpx•apoB Product as a Biomarker for Coronary Artery Disease

NCT ID: NCT07126132

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-12-31

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.

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).

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

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

Coronary Angiography

Intervention Type: 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).

Hpx•apoB Product Measurement

Intervention Type: 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)

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

Coronary Angiography

Intervention Type: 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).

Hpx•apoB Product Measurement

Intervention Type: 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.

Interventions

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).

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyan City Renmin Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qunxiong Fan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, China

Countries

China

Other Identifiers

syrmyy2018-079

Identifier Type: -

Identifier Source: org_study_id