NCT02894060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 5, 2016

Last Update Submit

September 5, 2016

Conditions

Cardiovascular Abnormalities

Keywords

Cardiovascular events

Outcome Measures

Primary Outcomes (1)

  • Blood level of immunologic biomarker PLox/apoB

    Day 0

Study Arms (1)

blood

EXPERIMENTAL

blood tests

Other: blood tests

Interventions

blood testsOTHER

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)

blood

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Michel ANDREJAK, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

FR(1)