Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Correlation of biomarkers with coronary artery disease burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Correlation of biomarkers with coronary artery disease burden
时间窗: 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.
次要结局
- Clinical events(12 months)
研究者
Shaoliang Chen, MD
Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital
Nanjing First Hospital, Nanjing Medical University