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Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease

Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05015270
Acronym
PREDICTION-NJ
Enrollment
900
Registered
2021-08-20
Start date
2021-07-21
Completion date
2021-12-30
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Biomarkers, Coronary artery disease, Disease burden, Clinical events

Brief summary

The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. The present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. Finally, the prediction of biomarkers for clinical events.

Detailed description

This study includes three parts: 1. Part 1 (Pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. Proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by Proteins 1-x. 2. Part 2 (Training group): Differentially expressed Proteins 1-x are measured and compared between patients with diameter stenosis \<70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. Finally, Proteins 1-y from Proteins 1-x will be identified. Subgroups stratified by single-, double-, and triple-vessel disease will be performed. 3. Part 3 (Validation group): The difference in blood concentration of Proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis \<70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.

Interventions

DIAGNOSTIC_TESTMedications or percutaneous coronary intervention

In this study, we will for the first analyze the correlation of proteins concentration with coronary artery disease burden. Next, the prediction of proteins for one-year clinical events will be further analyzed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* For Pilot study, both health and patients with at least one epicardial coronary artery disease are included * For both Training group and Validation group, patients must have at least one epicardial coronary artery disease * Left ventricular ejection fraction \> 30% * Stable or unstable angina * Myocardial infarction older than 1 month * No active inflammation * No scheduled non-cardiac surgery within 12 months * eGFR \> 30 ml/min/m2 * Patients agree to participate in this study

Exclusion criteria

* Severe liver dysfunction * Blood platelet count \<100 x 109/L * Cancer * On dialysis * Pulmonary hypertension (defined as mean pulmonary arterial pressure \> 25 mmHg and pulmonary vessel resistance \> 3.0 Woods Unit)

Design outcomes

Primary

MeasureTime frameDescription
Correlation of biomarkers with coronary artery disease burden12 monthsWe will analyze the differential level of proteins in peripheral blood between three groups. As a result, the correlation between biomarkers with disease burden will analyzed.

Secondary

MeasureTime frameDescription
Clinical events12 monthsClinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026