Assessment of Different Equations to Accurately Calculate LDL Cholesterol

NCT ID: NCT05598216

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

160000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Dyslipidemias Lipid Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fasting state

based on the sampling time and the serum's aspect

no intervention, Serum LDL cholesterol calculation

Intervention Type DIAGNOSTIC_TEST

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

no intervention, Serum LDL cholesterol calculation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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no intervention, Serum LDL cholesterol calculation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37678263 (View on PubMed)

Other Identifiers

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488

Identifier Type: -

Identifier Source: org_study_id

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