A Multinational Cohort Study to Determine the Incidence of Early Rheumatic Heart Disease (MEERCATS Study 1)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease
研究概览
简要总结
This study will look at how many children develop rheumatic heart disease (RHD) over a 3-year period. The study will include children ages 5 to 8 who do not have RHD at the start and who live in areas where the disease is common. Each child will have a heart ultrasound (echocardiogram) once a year for 3 years to check for signs of RHD. Doctors will diagnose RHD using internationally recognized guidelines from the World Heart Federation (2023). The study will also look at how often new cases occur each year, whether rates differ by age, sex, or location, and whether any children develop acute rheumatic fever during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-8 years at enrollment
- •Residence within participating study catchment area
- •Parent/guardian able to provide informed consent
- •Participant able to provide assent where age-appropriate (country-specific, see below)
- •Normal baseline echocardiogram according to study screening protocol
排除标准
- •History of past ARF or RHD with or without cardiac involvement
- •Evidence of RHD at baseline screening
- •Congenital heart disease at baseline screening (excluding small PFO/ASD)
- •Medical conditions that would preclude safe participation or follow-up
- •Anticipated inability to complete study follow-up
结局指标
主要结局
Number of Participants with 3-Year Cumulative Incidence of Rheumatic Heart Disease
时间窗: 3 years
Proportion of participants who develop RHD during the 3-year follow-up period, defined according to the 2023 World Heart Federation (WHF) echocardiographic criteria. Participants will be considered to have reached the endpoint if RHD is identified on any follow-up echocardiogram at 12, 24, or 36 months, or if they are diagnosed with acute rheumatic fever (ARF) during follow-up.
次要结局
- Rate of Newly Diagnosed Rheumatic Heart Disease(12 months, 24 months, and 36 months)
- Number of Participants with RHD by Age Group(3 years)
- Number of Participants with RHD by Sex(3 years)
- Number of Participants with RHD by Geographic Location(3 years)