LDL FORMULA: Assessment of Different Equations to Accurately Calculate LDL Cholesterol

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05598216
• Collaborator: (none)
• Enrollment: 160,000
• Location: 1
• Anticipated Duration (Months): 133
• Patients Per Site Per Month: 1203.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias; Lipid Disorder	Diagnostic Test: no intervention, Serum LDL cholesterol calculation

Study Design

• Study Type: Observational
• Actual Enrollment: 160000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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?
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Dec 30, 2021
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Fasting state based on the sampling time and the serum's aspect	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)
non-fasting state based on the sampling time and the serum's aspect	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)

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est	Bron		France	69677

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT05598216
• Other Study ID Numbers: 488
• First Posted: Oct 28, 2022
• Last Update Posted: Oct 28, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: LDL cholesterol; equation; postprandial; Dyslipidemia
• Additional relevant MeSH terms: Dyslipidemias; Lipid Metabolism Disorders

Study Results

No Results Posted as of Oct 28, 2022