Pilot Study for a National Screening for Familial Hypercholesterolemia

Familial Hypercholesterolemia Clinical Trial

— EARLIE  

Official title:

Pilot Study for a National Screening for Familial Hypercholesterolemia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05271305
• Other study ID #: FHC
• Status: Enrolling by invitation
• Start date: September 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Centre Hospitalier du Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Locations

Country	Name	City	State
Luxembourg	CHde Luxembourg	Luxembourg

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier du Luxembourg	Luxembourg Institute of Health

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	familial hypercholesteromia	percentage of screened primary school children with hypercholesterolemia	2021-2024
Secondary	percentage of children screened	number screened/number invited	2021-2024
Secondary	percentage of families screened	index case family screening	2021-2024