Antiphospholipid Syndrome
Conditions
Brief summary
The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time
Interventions
PROCEDUREDiffusion tensor imaging MRI
1. axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2. 2. Fluid-attenuated inversion recovery 3. three-dimensional axial image weighted in T1 4. axial echo-planar image sequence 5. three-dimensional pulse sequence axial flight time
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is at least 18 years old * For the target population: only women included in the publication by Pereira et al (2016) will be included, with no obsteric history (fetal death \>10 weeks or 3 unexplained consecutive losses \<10 weeks) * For the test group: Patients must be positive for antiphospholipid antibodies based on results from Pereira et al (2016) * For the control group. Patients must be negative for antiphospholipid antibodies according to results from Pereira et al (2016)
Exclusion criteria
* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant, parturient or breast feeding * The patient is claustrophobic * The patient has a metallic foreign body (e.g. pacemaker) * The patient has experienced pregnancy loss linked to infectious, metabolic, anatomic or hormonal factors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean diffusivity of white matter between groups | Day 0 | mm2/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional anisotropy of white matter between groups | Day 0 | Value between 0-1 |
| Radial diffusivity of white matter between groups | Day 0 | mm2/s |
| Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | Day 0 | mm2/s |
| Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | Day 0 | Value between 0-1 |
| Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | Day 0 | mm2/s |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Christophe Gris, MD
CHU Nimes
Outcome results
None listed