- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02803645
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects (SAPL)
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects: Study of Their Association With Cardiovascular Risk Factors, Markers of Arterial Inflammation and Markers of Oxidative Stress
Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies, predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA). Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the context of APS, APL can also be observed in various clinical situations and in healthy subjects. Published studies have reported a variable prevalence of APL in healthy subjects, essentially ACL and/or LA, and their clinical significance currently remains unclear.
Several studies have highlighted the link between APL and atherosclerosis. It therefore appears interesting to more specifically study the association between the presence of APL and the presence of cardiovascular risk factors in a population of healthy subjects. Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a complex interaction between atherogenic plasma factors and cells of the arterial wall. Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid peroxidation also plays a major role during the atherogenesis process. It will therefore also be important to correlate APL with markers of vascular inflammation and markers of oxidative stress.
A prospective case-control study will therefore be conducted on 1,500 healthy blood donors. Subjects screened APL-positive will be compared to APL-negative subjects in terms of cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular disease will not be studied). In the context of a blood donation, all subjects wishing to participate in this study will attend a medical interview and a clinical examination during which various data will be collected, mainly the presence of cardiovascular risk factors. A blood sample will also be taken to assay the various laboratory markers studied.
This study should provide a better understanding of the role of APL in healthy subjects and more clearly specify their possible link with atherosclerosis in this population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy blood donors
Exclusion Criteria:
- contraindication to blood donation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy
blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
antiphospholipid (APL) antibodies
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valéry SALLE, PhD, CHU Amiens
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRCIR05-DR-SALLE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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