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临床试验/NCT04261803
NCT04261803已完成不适用

Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
salivary cholesterol concentration

研究概览

简要总结

Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • poor dental health
  • for control patients: to have a known cholesterol disease

结局指标

主要结局

salivary cholesterol concentration

时间窗: Day 1

the sample will be obtained during one visit non dedicated to this study (following-visit in nutrition for hypercholesterolemia children and before surgery for control children), the swabs of all the 60 patients will be used in two different methods of enzymatic tests.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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