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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Medications or percutaneous coronary intervention

• Registration Number: NCT05015270
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2021-07-21
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-20
• Primary Completion: 2021-12-27
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Less disease group	Medications or percutaneous coronary intervention	Patients with coronary artery diameter stenosis \<70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion
Severe disease group	Medications or percutaneous coronary intervention	Patients with coronary artery stenosis ≥70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion

Primary Outcome Measures

Name	Time	Method
Correlation of biomarkers with coronary artery disease burden	12 months	We 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 Outcome Measures

Name	Time	Method
Clinical events	12 months	Clinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China