BIOKID: A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT02894060

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Abnormalities	Other: blood tests	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: blood blood tests	Other: blood tests 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)

Arm

Intervention/Treatment

Experimental: blood

blood tests

Other: blood tests

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)

Outcome Measures

Primary Outcome Measures

Blood level of immunologic biomarker PLox/apoB [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Michel ANDREJAK, MD, PhD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT02894060

Other Study ID Numbers:

PI2013_843_0019

First Posted:

Sep 9, 2016

Last Update Posted:

Sep 9, 2016

Last Verified:

Sep 1, 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens

Cardiovascular events

Additional relevant MeSH terms:

Cardiovascular Abnormalities

Study Results

No Results Posted as of Sep 9, 2016