Screening for Hypercholesterolemia in Children Using Dried Blood Spot (CHOLESPOT)

  • STATUS
    Recruiting
  • End date
    Jun 18, 2024
  • participants needed
    60
  • sponsor
    Hospices Civils de Lyon
Updated on 29 June 2022
atherosclerosis
blood test
hypercholesterolemia
cholesterol measurement
Accepts healthy volunteers

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

Details
Condition Hypercholesterolemia
Treatment Blood test
Clinical Study IdentifierNCT05191355
SponsorHospices Civils de Lyon
Last Modified on29 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

refusal to participate in the study
For control patients: to have a known dyslipidemia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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