Assessment of Different Equations to Accurately Calculate LDL Cholesterol

NCT05598216 | Unknown

• 1 other identifier: 488
• Study Type: observational
• Target: 160,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias; Lipid Disorder

Keywords

LDL cholesterol; equation; postprandial; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fasting state

based on the sampling time and the serum's aspect

Diagnostic Test: no intervention, Serum LDL cholesterol calculation

non-fasting state

based on the sampling time and the serum's aspect

Diagnostic Test: no intervention, Serum LDL cholesterol calculation

Interventions

no intervention, Serum LDL cholesterol calculation DIAGNOSTIC_TEST

The serum LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins)

Fasting state; non-fasting state

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

lipid profile performed in the lab during the recruitment period

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est

Bron, 69677, France

Location

Related Publications (1)

• Vasse J, Lassartesse A, Marmontel O, Charriere S, Bouveyron C, Marrie N, Moulin P, Di Filippo M. Assessment of three equations to calculate plasma LDL cholesterol concentration in fasting and non-fasting hypertriglyceridemic patients. Clin Chem Lab Med. 2023 Sep 8;62(2):270-279. doi: 10.1515/cclm-2023-0360. Print 2024 Jan 26.

  PMID: 37678263 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 28, 2022
• Study Start: November 1, 2014
• Primary Completion: December 30, 2021
• Study Completion: December 1, 2025
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

FR (1)