Clinical Precise Diagnosis and Treatment of Personalized Z-score Evaluation Combined With Genomic Analysis in the Repair of Coronary Artery Injury in Kawasaki Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Z-score of coronary artery
研究概览
简要总结
The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will acquire blood samples with complete clinical data and prognostic information. Using clinicopathology, molecular biology, gene diagnostics and other techniques to verify the expression differences of target genes and proteins and analyze their expression levels; To analyze the role of target genes and proteins in the occurrence and development of Kawasaki disease and their correlation with the risk of coronary artery injury. In vitro and in vivo KD (Kawasaki Disease) model was used to investigate the role of target genes in Kawasaki disease by gene interference and various molecular biological techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual patient's medical file data confirmed the diagnosis of KD using diagnostic criteria issued by the American Heart Association in 2017;
- •Patients were respond to IVIG treatment;
- •the patients aged from 2 months to 14 years old;
- •All included patients required to sign an informed consent form.
排除标准
- •The patients with severe infections;
- •The patients with a history of tuberculosis or recent close contact with tuberculosis;
- •The patient vaccinated with live vaccine in 6 months;
- •The patients with the application of hormone or other immunosuppressive agents;
- •The patients didn"t want to signed informed consent.
结局指标
主要结局
Z-score of coronary artery
时间窗: 4 weeks
Calculate z-score by using LMS regression form echocardiography data
Differential gene profile
时间窗: 1 week after IVIG treatment
Differential expression analysis of NGS sequencing in genomics
次要结局
未报告次要终点