Rheumatic Heart DiseaseNCT00779662
The Prevalence of Rheumatic Heart Disease in School Children in Fiji
An observational study of Rheumatic Heart Disease, run by Queensland Institute of Medical Research.
Trial summary
This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions.
Who may be able to join
- Informed consent will be obtained for all participants
- All children between the ages of 5-14 Years are eligible for the study.
Who cannot join
- None
About this study
This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School children will be enrolled after informed consent has been obtained. A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. All children with or without murmur will have a screening echocardiogram performed at a subsequent visit. Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.
- Conditions
- Rheumatic Heart Disease
- Keywords
- Rheumatic Heart Disease, Streptococcus, Fiji
- Medical subject headings
- Rheumatic Heart Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Menzies School of Health Research, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779662
- Sponsor's protocol ID
- 07- 0070
- Other IDs
- U01AI060579
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Rheumatic Heart Disease in School Children in Fiji
- ClinicalTrials.gov ID
- NCT00779662
- Acronym / sponsor ID
- 07- 0070
- Conditions
- Rheumatic Heart Disease
- Keywords
- Rheumatic Heart Disease, Streptococcus, Fiji
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Queensland Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Menzies School of Health Research, University of Melbourne
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School children will be enrolled after informed consent has been obtained. A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. All children with or without murmur will have a screening echocardiogram performed at a subsequent visit. Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions.
Key inclusion criteria (2 listed)
- Informed consent will be obtained for all participants
- All children between the ages of 5-14 Years are eligible for the study.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
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Rheumatic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease, run by Queensland Institute of Medical Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.