Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

Study Overview
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Brief Summary
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The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time

Official Title
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Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

Conditions
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Antiphospholipid Syndrome

Intervention / Treatment
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* Procedure: Diffusion tensor imaging MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br> | Procedure: Diffusion tensor imaging MRI<br>* axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2. Fluid-attenuated inversion recovery three-dimensional axial image weighted in T1 axial echo-planar image sequence three-dimensional pulse sequence axial flight time<br>|
| Other: antiphospholipid syndrome patients<br> | Procedure: Diffusion tensor imaging MRI<br>* axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2. Fluid-attenuated inversion recovery three-dimensional axial image weighted in T1 axial echo-planar image sequence three-dimensional pulse sequence axial flight time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean diffusivity of white matter between groups | mm2/s | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional anisotropy of white matter between groups | Value between 0-1 | Day 0 | 
| Radial diffusivity of white matter between groups | mm2/s | Day 0 | 
| Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | mm2/s | Day 0 | 
| Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | Value between 0-1 | Day 0 | 
| Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies | mm2/s | Day 0 |