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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02188862 |
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Date of registration:
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10/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Genetic Susceptibility to Rheumatic Heart Disease in the Pacific Region
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Scientific title:
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Genome-wide Association Study of Susceptibility to Rheumatic Heart Disease in Fiji and New Caledonia |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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2372 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02188862 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Fiji
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New Caledonia
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United Kingdom
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Contacts
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Name:
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Adrian VS Hill, DPhil DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oxford |
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Name:
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Mariana Mirabel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut National de la Santé Et de la Recherche Médicale, France |
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Name:
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Tom Parks, MRCP DTM&H |
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Address:
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Email:
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Affiliation:
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University of Oxford |
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Name:
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Andrew C Steer, FRACP PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Melbourne |
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Key inclusion & exclusion criteria
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1. Cases
1. Inclusion Criteria:
- Diagnosis of rheumatic heart disease based on one of:
- World Heart Federation definite echocardiographic criteria
- World Heart Federation borderline echocardiographic criteria and
history of acute rheumatic fever
- Mitral stenosis with valve area less than 2.0 cm2
- Previous surgery for rheumatic heart disease
2. Exclusion Criteria:
- Age less than five years
- Inability to give consent
2. New Controls
1. Inclusion criteria:
- Healthy individual living in a community where cases were identified
2. Exclusion Criteria:
- Past medical history or systems suggestive of rheumatic heart disease,
acute rheumatic fever or other valvular heart disease
- Age less than five years
- Inability to give consent
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mitral Stenosis
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Rheumatic Heart Disease
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Primary Outcome(s)
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Rheumatic heart disease diagnosis
[Time Frame: At enrolment]
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Secondary Outcome(s)
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Mitral stenosis diagnosis
[Time Frame: At enrolment]
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Secondary ID(s)
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PACIFICRHDGEN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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