Rheumatic Heart Disease Prevalence in Leon, Nicaragua
Condition: Streptococcus Group A
MeSH terms: Rheumatic Heart Disease; Rheumatic Diseases; Heart Diseases
Study type: Observational

Summary: 
      A bacterium called Group A Steptoccoccus or "strep" is commonly found in the nose and throat
      of healthy adults and children and can cause a variety of illnesses. If this bacterium
      infects another part of the body one or more times, children may get Rheumatic heart disease
      (RHD). The purpose of this community based study is to see how many children between 5-15
      years of age have RHD in Leon, Nicaragua. The study will also help to determine if the usual
      methods of detecting this disease are working. Researchers hope that this study will help to
      develop vaccines that may prevent "strep" infections to Nicaragua and other parts of the
      world. About 3,600 children will take part in the study. The children will participate for a
      minimum of 1 day and have a 6 month follow-up visit if they are identified as possible or
      probable RHD cases. Study procedures will include clinical exams and echocardiograms to
      determine the presence of RHD.
    

Detailed description: 
      Group A streptococcal (GrAS) infections are responsible for a wide spectrum of clinical
      syndromes, ranging from uncomplicated throat infections to life-threatening invasive
      infections. Some cases of uncomplicated and untreated pharyngitis may trigger the onset of
      acute rheumatic fever (ARF) accompanied by rheumatic heart disease (RHD). ARF is the most
      common cause of heart disease in children around the world and is associated with early
      morbidity and mortality. The most cost-effective method of preventing ARF and RHD would be
      vaccine prevention of the streptococcal infections that trigger the disease. Unfortunately,
      the overall burden of RHD in developing countries is unknown. This information is needed to
      adequately assess the potential risk- and cost-benefits of a GrAS vaccine that may eventually
      be introduced in countries where ARF and RHD are prevalent. The primary objective of this
      study is to determine the prevalence of RHD among children aged 5-15 in Leon. The secondary
      objective is to determine the sensitivity and specificity of clinical examination of the
      heart in an area of suspected high prevalence of RHD (Leon). This is an uncontrolled,
      observational, community-based study designed to provide detailed information about the
      prevalence of RHD in children in León, Nicaragua. Children and adolescents between the ages
      of 5 and 15 will be eligible for enrollment. Centro de Investigación en Demografía y Salud
      (CIDS - Center for Investigation of Demography and Health) staff will visit randomly selected
      dwellings with children between the target ages of 5 and 15 years, explain the nature and
      purpose of the study, and obtain signed informed consent from the parents or guardians of the
      children to collect demographic information. The study will also be discussed with all
      children 13 years of age or older, and their verbal agreement to participate in the study
      will be sought. After informed consent has been obtained and children are enrolled, CIDS
      staff will administer a questionnaire to capture the children's demographics. All enrolled
      children and their parent(s) from a given area will be offered transportation to the
      rheumatic heart disease clinic at HEODRA by van. CIDS staff will arrange the examinations and
      transportation and will inform the families appropriately. All children whose
      parent(s)/guardian provide informed consent will have at least one study visit at HEODRA. On
      the day of the scheduled clinic visit, the families will be informed again in detail about
      the RHD research study and written informed consent will again be obtained. All children who
      participate in the study will have an auscultation and a screening echocardiogram as part of
      the study. Those children who are identified by auscultation and/or by echocardiography to be
      in the "probable or possible rheumatic heart disease" groups will be asked to return for
      repeat echocardiography 6 months after their first examination. The primary and secondary
      endpoints of the study will be clinical diagnosis of RHD as confirmed by echocardiogram.
    

Time perspective: Prospective
Keywords: Group A streptococcus, Nicaragua, Rheumatic Heart Disease