跳至主要内容
临床试验/NCT05598216
NCT05598216进行中(未招募)不适用

LDL Cholesterol: Friedewald, Always the Best Option to Evaluate LDL cholesteRol Concentration in norMal and Dyslipidemic sUbjects, in Fasting and Pot-prandiaL State?

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 160,000 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
160,000
试验地点
1
主要终点
Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)

研究概览

简要总结

Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.

New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .

Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis

To evaluate the most accurate equation in different conditions:

  • Fasting and non-fasting state
  • In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • lipid profile performed in the location 1 during the recruitment period

排除标准

  • Results outside the first and 99th percentile for TG parameters
  • Samples slightly opalescent

结局指标

主要结局

Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)

时间窗: The outcome measure will be assessed through study completion, an average of 1 year

The outcome measure is LDL cholesterol concentration (mmol/l or g/L) determined using different equations (Friedwald, Martin Hopkins, Sampson equations, ...) and measured.

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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