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

NCT ID: NCT05015270

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2021-12-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Less disease group

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

Medications or percutaneous coronary intervention

Intervention Type: DIAGNOSTIC_TEST

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

Severe disease group

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

Medications or percutaneous coronary intervention

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Medications 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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Percutaneous coronary intervention

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen, MD

Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shao-Liang M Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NMU20211033

Identifier Type: -

Identifier Source: org_study_id