Screening for Hypercholesterolemia in Children Using Dried Blood Spot

Completed

• Conditions: Hypercholesterolemia
• Interventions: Biological: blood test

• Registration Number: NCT05191355
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Purpose:

Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.

Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.

The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement

Hypothesis

* to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia

* to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-13
• Study Start: 2022-05-18
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients/kindreds in family with a documented history of hypercholesterolemia
• healthy subjects for controls

Read More

Exclusion Criteria

• refusal to participate in the study
• For control patients: to have a known dyslipidemia

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subjects with familial hypercholesterolemia	blood test	blood test
healthy subjects	blood test	blood test

Primary Outcome Measures

Name	Time	Method
Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling	Day 0	study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia

Trial Locations

Locations (2)

Hospices Civils de Lyon, Dept of Endocrinology; 🇫🇷 Bron, France

Hospices Civils de Lyon, Service d'Hépatologie et de Gastro-Entérologie et Nutrition Pédiatrique; 🇫🇷 Bron, France