Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,379
- 试验地点
- 1
- 主要终点
- Susceptibility of coronary artery aneurysms for Kawasaki patients
研究概览
简要总结
Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. An infectious aetiology is suspected, but the causative agent has not been identified. The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
详细描述
The problem to be addressed;
Kawasaki disease is now the most common cause of acquired heart disease in children in Japan and North America. Kawasaki disease arises when genetically predisposed children encounter an as yet unidentified infectious agent which may cause only mild illness or no illness at all in children without the genetic predisposition. Other children may suffer permanent damage to the coronary arteries. Identification of the genes involved will help to improve understanding of the disease, and the development of better treatments.
Objective
The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affected children will be recruited if the treating clinician has made a diagnosis of possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease).
- •The current standard diagnostic criteria for KD (Circulation 2001 103 335-336 doi: 10.1161/01.CIR 103.2.335) are:
- •The presence of fever for at least five days plus four of the following criteria:
- •Changes in the peripheral extremities Acute: erythema and oedema of hands and feet Convalescent: membranous desquamation of fingertips
- •Polymorphous exanthema
- •Bilateral painless bulbar conjunctival injection without exudate
- •Changes in lips and oral cavity: erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
- •Cervical lymphadenopathy (>1.5cm diameter), usually unilateral Patients meeting not all of these criteria may meet the criteria for atypical Kawasaki disease, ie. if they have fever and two or three of the above criteria and elevation of CRP or echocardiographic evidence of coronary artery dilatation.
- •Parents of affected child must be biological parents.
排除标准
- •children who do not have a diagnosis of possible Kawasaki disease
结局指标
主要结局
Susceptibility of coronary artery aneurysms for Kawasaki patients
时间窗: end date; 30 December 2022
Identification of genes that are associated with susceptibility of coronary artery aneurysms
次要结局
- Disease severity for Kawasaki patients(end date; 30 December 2022)