Hpx•apoB Product as a Biomarker for Coronary Artery Disease

Shiyan City Renmin Hospital

Status: Completed

Conditions: Coronary Artery Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT07126132

syrmyy2018-079

Details and patient eligibility

About

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.

Full 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).

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

460 participants in 2 patient groups

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

Description:

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

Treatment:

Procedure: Coronary Angiography

Diagnostic Test: Hpx•apoB Product Measurement

Control Group (n=110)

Description:

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

Treatment:

Procedure: Coronary Angiography

Diagnostic Test: Hpx•apoB Product Measurement