Pilot Study for a National Screening for Familial Hypercholesterolemia
NCT ID: NCT05271305
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2021-09-04
2023-12-31
Brief Summary
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The pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.
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Detailed Description
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Cross-sectional design. Primary outcome Percentage of screened school children with confirmed familial hypercholesterolemia Participants All children, who attend a public primary school in the city of Luxembourg and are enrolled in the cycle C2.2 (age of 7-8 years; 3rd medical visit at school), cycle C3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. Expected number of invited children is around 1600 children/year.
Recruitment will take place during the school year 2021/2022 and 2022/2023. The parents/caregivers of these children will receive written information about the screening. They will receive as well a questionnaire on the family history of premature cardiovascular events and known FHC disease.
Without informed consent, the child cannot be included in the screening program.
All children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) All data (pseudonymised) on each participant will be entered in the online data base for further analysis.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
13 Years
ALL
Yes
Sponsors
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Luxembourg Institute of Health
OTHER_GOV
Centre Hospitalier du Luxembourg
OTHER
Responsible Party
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Carine de Beaufort
professor pediatrics
Principal Investigators
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Carine de Beaufort, MPhD
Role: PRINCIPAL_INVESTIGATOR
CHL
Marianne Becker, MD
Role: PRINCIPAL_INVESTIGATOR
CHL
Locations
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CHde Luxembourg
Luxembourg, , Luxembourg
Countries
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References
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Becker M, Adamski A, Fandel F, Vaillant M, Wagner K, Droste DW, Ziade B, Hein S, Mendon P, Bocquet V, de Beaufort C. Screening for familial hypercholesterolaemia in primary school children: protocol for a cross-sectional, feasibility study in Luxembourg city (EARLIE). BMJ Open. 2022 Dec 9;12(12):e066067. doi: 10.1136/bmjopen-2022-066067.
Other Identifiers
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FHC
Identifier Type: -
Identifier Source: org_study_id
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