Screening for Familial Hypercholesterolemia in Children Using the Blotter Method, or Dried Blood Spot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients/kindreds in family with a documented history of hypercholesterolemia
- •healthy subjects for controls
排除标准
- •refusal to participate in the study
- •For control patients: to have a known dyslipidemia
结局指标
主要结局
Comparison of lipid profile (total cholesterol, LDL cholesterol concentrations) between venous blood and blotter method for sampling
时间窗: Day 0
study of the feasibility and accuracy of the blotter method to screen hypercholesterolemia
次要结局
未报告次要终点