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

Coronary Artery Disease Clinical Trial

— PREDICTION-NJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015270
• Other study ID #: NMU20211033
• Status: Completed
• Start date: July 21, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 30, 2021
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of biomarkers with coronary artery disease burden	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.	12 months
Secondary	Clinical events	Clinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography	12 months