Clinical trial NCT05271305: Pilot Study for a National Screening for Familial Hypercholesterolemia
Official title: Pilot Study for a National Screening for Familial Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Hypercholesterolemia
Lead sponsor: Centre Hospitalier du Luxembourg
Sponsor class: OTHER
Collaborators: name: Luxembourg Institute of Health
First posted: 2022-03-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children, invited for their medical check through school medicine unit of the city of luxembourg, are invited to participate

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.

Eligibility criteria: 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

Primary outcomes:
measure: familial hypercholesteromia
timeFrame: 2021-2024
Secondary outcomes:
measure: percentage of children screened
timeFrame: 2021-2024
measure: percentage of families screened
timeFrame: 2021-2024
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: CHde Luxembourg
Study officials:
affiliation: CHL
name: Carine de Beaufort, MPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHL
name: Marianne Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: