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

Study Overview
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Brief Summary
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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
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This study includes three parts: 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. 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. 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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Medications or percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Less disease group<br>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 | Diagnostic Test: Medications or percutaneous coronary intervention<br>* 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<br>* Other names: Percutaneous coronary intervention;|
| Severe disease group<br>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 | Diagnostic Test: Medications or percutaneous coronary intervention<br>* 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<br>* Other names: Percutaneous coronary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical events | Clinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Coronary artery disease, Disease burden, Clinical events