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Rheumatic Heart Disease Study in Lusaka

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ClinicalTrials.gov Identifier: NCT02661763
Recruitment Status : Completed
First Posted : January 22, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborators:
University of Cape Town
Novartis
Information provided by (Responsible Party):
John Musuku, University of Zambia

Brief Summary:
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.

Condition or disease
Rheumatic Heart Disease

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1024 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Prevalence of Rheumatic Heart Disease in Zambian Schoolchildren: an Echocardiographic Screening Study Involving Task-shifting to General Radiographers
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort
Schoolchildren in Zambia
Schoolchildren in grades 7-12 in fifteen randomly selected schools in Lusaka area



Primary Outcome Measures :
  1. Prevalence of RHD in Lusaka schoolchildren [ Time Frame: Cross-sectional; the screening period is anticipated to last 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A population of approximately 1,024 schoolchildren drawn from 15 primary and secondary schools in Lusaka, Zambia, to be screened for RHD in order to determine prevalence of the disease.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661763


Locations
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Zambia
University Teaching Hosptial
Lusaka, Zambia
Sponsors and Collaborators
University of Zambia
University of Cape Town
Novartis
Investigators
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Principal Investigator: John Musuku, Doctor University of Zambia / University Teaching Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Musuku, Consultant Paediatrician / Cardiologist, University of Zambia
ClinicalTrials.gov Identifier: NCT02661763     History of Changes
Other Study ID Numbers: UNZABREC 002-10-13
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Musuku, University of Zambia:
Rheumatic heart disease

Additional relevant MeSH terms:
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Heart Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections