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Pilot Study for a National Screening for Familial Hypercholesterolemia

Pilot Study for a National Screening for Familial Hypercholesterolemia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05271305
Acronym
EARLIE
Enrollment
2000
Registered
2022-03-09
Start date
2021-09-04
Completion date
2023-12-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia

Brief summary

A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school. 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.

Detailed description

Pilot study evaluating the feasibility of a screening for familial hypercholesterolemia. 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.

Interventions

None listed

Sponsors

Luxembourg Institute of Health
CollaboratorOTHER_GOV
Centre Hospitalier du Luxembourg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

1\. Attending primary school in the city of Luxembourg and invited for the legal medical visit

Exclusion criteria

1\. No parental informed consent

Design outcomes

Primary

MeasureTime frameDescription
familial hypercholesteromia2021-2024percentage of screened primary school children with hypercholesterolemia

Secondary

MeasureTime frameDescription
percentage of children screened2021-2024number screened/number invited
percentage of families screened2021-2024index case family screening

Countries

Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026