Assessment of Different Equations to Accurately Calculate LDL Cholesterol

Dyslipidemias Clinical Trial

— LDL FORMULA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05598216
• Other study ID #: 488
• Status: Active, not recruiting
• Start date: November 1, 2014
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160000
• Est. completion date: December 2025
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Lipid Disorder
• Lipid Metabolism Disorders

Intervention

Diagnostic Test:
• no intervention, Serum LDL cholesterol calculation
The serum LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins)

Locations

Country	Name	City	State
France	Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the most accurate equation to calculate LDL cholesterol (mmo/L or g/L)	The outcome measure is LDL cholesterol concentration (mmol/l or g/L) determined using different equations (Friedwald, Martin Hopkins, Sampson equations, …) and measured.	The outcome measure will be assessed through study completion, an average of 1 year