NCT05271305

Pilot Study for a National Screening for Familial Hypercholesterolemia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Centre Hospitalier du Luxembourg · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Familial Hypercholesterolemia

Timeline

• Start date: 2021-09-04
• Primary completion: 2023-07-30
• Completion: 2023-12-31
• First posted: 2022-03-09
• Last updated: 2022-03-09

Locations

1 site across 1 country: Luxembourg