Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894060
Other study ID # PI2013_843_0019
Secondary ID
Status Completed
Phase N/A
First received September 5, 2016
Last updated September 5, 2016
Start date June 2014
Est. completion date June 2016

Study information

Verified date September 2016
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood level of immunologic biomarker PLox/apoB Day 0 No
See also
  Status Clinical Trial Phase
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Active, not recruiting NCT02973126 - Heartflow (AFFECTS) Phase 3
Completed NCT01410487 - Effects of Weight Loss on Cardio-respiratory Function N/A
Withdrawn NCT00844935 - Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients N/A
Withdrawn NCT00807274 - Renal Function in Adults With Congenital Heart Disease. N/A
Withdrawn NCT00468702 - Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial N/A
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Completed NCT03758092 - Cardiovascular Screening in Infants Born Small for Gestational Age
Recruiting NCT06091384 - Inspiratory Muscle Strength Training in Post-Covid Syndrome N/A
Completed NCT04586894 - Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Completed NCT03826914 - The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults N/A
Not yet recruiting NCT05624255 - Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score N/A
Completed NCT02966028 - Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD) Phase 2
Completed NCT01820702 - Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation N/A
Recruiting NCT04766203 - Relative Energy Deficiency in Sport Multicenter Study N/A
Completed NCT01811667 - Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations Phase 3
Terminated NCT02351726 - Mitroflow DL Post Approval Study- North America N/A
Completed NCT02616913 - Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects N/A
Completed NCT00901394 - Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia N/A