Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects (SAPL)
Primary Purpose
Antiphospholipid Antibodies
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Antiphospholipid Antibodies focused on measuring healthy subjects, cardiovascular risk factors, markers of arterial inflammation, markers of oxidative stress
Eligibility Criteria
Inclusion Criteria:
- healthy blood donors
Exclusion Criteria:
- contraindication to blood donation
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healthy
Arm Description
blood sample
Outcomes
Primary Outcome Measures
antiphospholipid (APL) antibodies
Secondary Outcome Measures
Full Information
NCT ID
NCT02803645
First Posted
June 9, 2016
Last Updated
June 14, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02803645
Brief Title
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects
Acronym
SAPL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Antibodies
Keywords
healthy subjects, cardiovascular risk factors, markers of arterial inflammation, markers of oxidative stress
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
1282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy
Arm Type
Experimental
Arm Description
blood sample
Intervention Type
Biological
Intervention Name(s)
blood sample
Primary Outcome Measure Information:
Title
antiphospholipid (APL) antibodies
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy blood donors
Exclusion Criteria:
contraindication to blood donation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéry SALLE, 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
Learn more about this trial
Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects
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