Coronary Artery DiseaseNCT07126132
Hpx•apoB Product as a Biomarker for Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shiyan City Renmin Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Angiography and Hpx•apoB Product Measurement
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years.
- Referred for coronary angiography due to suspected or known CAD.
- Provided written informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Coronary Angiography, Hpx•apoB Product Measurement
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyProcedure or surgery
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 MeasurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) Group (n=350) | Patients with angiographically confirmed stenosis of ≥50% in at least one major epicardial artery. Receives: Procedure: Coronary Angiography; Diagnostic Test: Hpx•apoB Product Measurement | |
| 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%). Receives: Procedure: Coronary Angiography; Diagnostic Test: Hpx•apoB Product Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product
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.
Measured: Baseline
Change in Area Under the Receiver Operating Characteristic Curve (AUC)
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.
Measured: Baseline
Secondary outcomes (6)
Comparison of Hpx•apoB Product Concentration by Number of Diseased Vessels
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.
Measured: Baseline
Correlation Between Hpx•apoB Product and Gensini Score
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.
Measured: Baseline
Correlation Between Hpx•apoB Product and High-Sensitivity C-Reactive Protein (hs-CRP)
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.
Measured: Baseline
Correlation Between Hpx•apoB Product and Low-Density Lipoprotein Cholesterol (LDL-C)
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.
Measured: Baseline
Correlation Between Hpx•apoB Product and Triglycerides (TG)
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.
Measured: Baseline
Correlation Between Hpx•apoB Product and Estimated Glomerular Filtration Rate (eGFR)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyan City Renmin Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qunxiong Fan, Shiyan City Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126132
- Sponsor's protocol ID
- syrmyy2018-079
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemopexin-Apolipoprotein B Product: A Novel Biomarker Integrating Oxidative Stress and Lipid Metabolism for Coronary Artery Disease Risk Stratification
- ClinicalTrials.gov ID
- NCT07126132
- Acronym / sponsor ID
- syrmyy2018-079
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Shiyan City Renmin HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) Group (n=350) | – | Procedure: Coronary Angiography, Diagnostic Test: Hpx•apoB Product MeasurementPatients with angiographically confirmed stenosis of ≥50% in at least one major epicardial artery. |
| Control Group (n=110) | – | Procedure: Coronary Angiography, Diagnostic Test: Hpx•apoB Product MeasurementSubjects who underwent coronary angiography for symptoms such as chest pain but were found to have no significant coronary stenosis (<50%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥18 years.
- Referred for coronary angiography due to suspected or known CAD.
- Provided written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary AngiographyStandard 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). | Procedure or surgery | Control Group (n=110), Coronary Artery Disease (CAD) Group (n=350) |
| Hpx•apoB Product MeasurementFasting 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. | Diagnostic test | Control Group (n=110), Coronary Artery Disease (CAD) Group (n=350) |
Primary outcome
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.
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.
6 secondary outcomes
Comparison of Hpx•apoB Product Concentration by Number of Diseased Vessels
Time frame: Baseline
Correlation Between Hpx•apoB Product and Gensini Score
Time frame: Baseline
Correlation Between Hpx•apoB Product and High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline
Correlation Between Hpx•apoB Product and Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline
Correlation Between Hpx•apoB Product and Triglycerides (TG)
Time frame: Baseline
Correlation Between Hpx•apoB Product and Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shiyan City Renmin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds Ratio for the Presence of Coronary Artery Disease per Unit Increase in Hpx•apoB Product (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.