Clinical trial NCT03600636: Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Official title: Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antiphospholipid Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time


Eligibility criteria: 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

Primary outcomes:
measure: Mean diffusivity of white matter between groups
timeFrame: Day 0
Secondary outcomes:
measure: Fractional anisotropy of white matter between groups
timeFrame: Day 0
measure: Radial diffusivity of white matter between groups
timeFrame: Day 0
measure: Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
timeFrame: Day 0
measure: Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
timeFrame: Day 0
measure: Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Jean-Christophe Gris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pereira FR, Macri F, Jackowski MP, Kostis WJ, Gris JC, Beregi JP, Mekkaoui C. Diffusion tensor imaging in patients with obstetric antiphospholipid syndrome without neuropsychiatric symptoms. Eur Radiol. 2016 Apr;26(4):959-68. doi: 10.1007/s00330-015-3922-x. Epub 2015 Jul 23.