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临床试验/NCT02661763
NCT02661763已完成不适用

Prevalence of Rheumatic Heart Disease in Zambian Schoolchildren: an Echocardiographic Screening Study Involving Task-shifting to General Radiographers

University of Zambia1 个研究点 分布在 1 个国家目标入组 1,024 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,024
试验地点
1
主要终点
Prevalence of RHD in Lusaka schoolchildren

研究概览

简要总结

This study will determine the prevalence of rheumatic heart disease (RHD) in Lusaka, Zambia through school-based screening methodology using ultraportable echocardiography and a recently validated, abridged screening protocol based on World Heart Federation criteria. Children that screen positive for RHD at schools will undergo confirmatory evaluation at University Teaching Hospital (UTH), Lusaka's main referral hospital.

详细描述

It has been estimated that RHD affects over 32 million people worldwide, with the vast majority of cases occurring in the developing world. RHD is the most common cardiovascular disease in children and young adults and is a major cause of death in children above the age of 5 in many parts of the developing world, particularly sub-Saharan Africa.

RHD results from repeated attacks of acute rheumatic fever (ARF). ARF is a systemic inflammatory disease occurring mainly in children, characterized by fever, painful joints, and heart, skin, and neurological manifestations. ARF is linked with preceding Group A streptococcal (GAS) throat infections, which, if left untreated, carry an estimated 2-3% risk of developing ARF.

The pathologic hallmark of RHD is classically a valvulitis that affects mostly the mitral and/or aortic valves. Inflammation of the myocardium and pericardium may exacerbate the effects of valvular insufficiency, resulting in congestive heart failure, stroke and other complications. Over time, severe disability or death can ensue, especially in developing countries where the management of RHD patients is challenging and surgical interventions are not readily available.

ARF and RHD are diseases of poverty, especially in countries with limited healthcare systems. GAS thrives in situations of over-crowding where poor nutrition and sanitation are common and where medical treatment for sore throat is not readily available. For these reasons, RHD is endemic in many parts of the developing world, particularly sub-Saharan Africa, while it almost disappeared from most parts of the developed world (except for indigenous populations in some countries). It should be noted that the initial decline of ARF/RHD in the US and Europe most likely was due to improved living conditions and hygiene (primordial prevention), since it predated the introduction of penicillin.

RHD is one of few truly preventable chronic diseases. Currently, many sub-Saharan African countries do not focus efforts on primary and secondary prevention due to lack of resources. The long-term goal of an ongoing effort in Zambia is to develop capability to provide effective primary and secondary prevention of RHD, with the ultimate goal of eliminating new cases.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Schoolgoing children in Lusaka in grades 7-12 at one of the participating primary or secondary schools
  • Written parental consent
  • Written assent by children
  • Present on the day of school screening

排除标准

  • Children whose parents do not provide consent
  • Children who do not provide assent
  • Children with health problems (e.g., skin infection of the chest) that preclude performance of transthoracic echocardiography

结局指标

主要结局

Prevalence of RHD in Lusaka schoolchildren

时间窗: Cross-sectional; the screening period is anticipated to last 5 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Musuku

Consultant Paediatrician / Cardiologist

University of Zambia

研究点 (1)

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