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A Study of Immunological Biomarkers as Predictors of Cardiovascular Events (BIOKID)

Primary Purpose

Cardiovascular Abnormalities

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood tests
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Abnormalities focused on measuring Cardiovascular events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

blood

Arm Description

blood tests

Outcomes

Primary Outcome Measures

Blood level of immunologic biomarker PLox/apoB

Secondary Outcome Measures

Full Information

First Posted
September 5, 2016
Last Updated
September 5, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02894060
Brief Title
A Study of Immunological Biomarkers as Predictors of Cardiovascular Events
Acronym
BIOKID
Official Title
A Study of Immunological Biomarkers as Predictors of Cardiovascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Abnormalities
Keywords
Cardiovascular events

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blood
Arm Type
Experimental
Arm Description
blood tests
Intervention Type
Other
Intervention Name(s)
blood tests
Intervention Description
Blood tests done by the nurse in the CRC (clinical research center). The quantity of blood taken wil be (3 5-mL tubes): 2 plain tubes and 1EDTA tube Arterial blood pressure will be measured at the CRC. Then, an X-ray of the profile of the abdomen will be taken without preparation to evaluate aortic calcification (in the radiology department of the Amiens hospital)
Primary Outcome Measure Information:
Title
Blood level of immunologic biomarker PLox/apoB
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Dementia Persons under legal protection Malnutrition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel ANDREJAK, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

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