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Clinical Trials/NCT02894060
NCT02894060
Completed
Not Applicable

A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

Centre Hospitalier Universitaire, Amiens1 site in 1 country84 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Abnormalities
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
84
Locations
1
Primary Endpoint
Blood level of immunologic biomarker PLox/apoB
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Persons under legal protection
  • Malnutrition

Outcomes

Primary Outcomes

Blood level of immunologic biomarker PLox/apoB

Time Frame: Day 0

Study Sites (1)

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