Pilot Study for a National Screening for Familial Hypercholesterolemia

• Conditions: Familial Hypercholesterolemia

• Registration Number: NCT05271305
• Lead Sponsor: Centre Hospitalier du Luxembourg

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.

Study Timeline

• Study Start: 2021-09-04
• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Study First Posted: 2022-03-09
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-07-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
familial hypercholesteromia	2021-2024	percentage of screened primary school children with hypercholesterolemia

Secondary Outcome Measures

Name	Time	Method
percentage of children screened	2021-2024	number screened/number invited
percentage of families screened	2021-2024	index case family screening

Trial Locations

Locations (1)

CHde Luxembourg; 🇱🇺 Luxembourg, Luxembourg