A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

Not Applicable

Completed

• Conditions: Cardiovascular Abnormalities
• Interventions: Other: blood tests

• Registration Number: NCT02894060
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents) are one of the main causes of mortality in the general population. The recruitment of macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are rarely followed by clinical events, but can progress to complicated atheromatoses (calcification, rupture) resulting in the occurrence of various clinical events such as myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes immunogenic and induces anti-LDLox antibody production that could be markers of progression of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE) such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are generated. In order to measure the level of markers in the blood, researchers developed a series of immunologic levels in vitro, using specific antibodies directed against well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36 (sCD36) was recently identified. In this study, only healthy volunteers were recruited in order to be able to establish normal serum ranges of different immunologic biomarkers.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Last Update Submitted: 2016-09-05
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Healthy adults
• Persons providing signed informed consent
• Persons with healthcare coverage

Exclusion Criteria

• Renal disease
• Cardiovascular disease
• Auto immune disease
• Pregnancy in progress
• Infection
• Dementia
• Persons under legal protection
• Malnutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood	blood tests	blood tests

Primary Outcome Measures

Name	Time	Method
Blood level of immunologic biomarker PLox/apoB	Day 0

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France