Assessment of Different Equations to Accurately Calculate LDL Cholesterol

Active, not recruiting

• Conditions: Dyslipidemias; Lipid Disorder
• Interventions: Diagnostic Test: no intervention, Serum LDL cholesterol calculation

• Registration Number: NCT05598216
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2021-12-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-fasting state	no intervention, Serum LDL cholesterol calculation	based on the sampling time and the serum's aspect
Fasting state	no intervention, Serum LDL cholesterol calculation	based on the sampling time and the serum's aspect

Primary Outcome Measures

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

Trial Locations

Locations (1)

Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est; 🇫🇷 Bron, France