Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT07126132
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).
Study:
NCT07126132
Study Brief:
Protocol Section:
NCT07126132