The Hemopexin-Apolipoprotein B Product: A Novel Biomarker Integrating Oxidative Stress and Lipid Metabolism for Coronary Artery Disease Risk Stratification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years.
- •Referred for coronary angiography due to suspected or known CAD.
- •Provided written informed consent.
排除标准
- •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.
结局指标
主要结局
Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product
时间窗: 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.
Change in Area Under the Receiver Operating Characteristic Curve (AUC)
时间窗: 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.
次要结局
- 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)
- Correlation Between Hpx•apoB Product and Estimated Glomerular Filtration Rate (eGFR)(Baseline)
研究者
Qunxiong Fan
Principal investigator
Shiyan City Renmin Hospital