Skip to main content
Clinical Trials/NCT05015270
NCT05015270
Completed
Not Applicable

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

Nanjing First Hospital, Nanjing Medical University1 site in 1 country900 target enrollmentJuly 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Nanjing First Hospital, Nanjing Medical University
Enrollment
900
Locations
1
Primary Endpoint
Correlation of biomarkers with coronary artery disease burden
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaoliang Chen, MD

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

Nanjing First Hospital, Nanjing Medical University

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
  • On dialysis
  • Pulmonary hypertension (defined as mean pulmonary arterial pressure \> 25 mmHg and pulmonary vessel resistance \> 3.0 Woods Unit)

Outcomes

Primary Outcomes

Correlation of biomarkers with coronary artery disease burden

Time Frame: 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 Outcomes

  • Clinical events(12 months)

Study Sites (1)

Loading locations...

Similar Trials