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

Not Applicable

Completed

• Conditions: Antiphospholipid Syndrome
• Interventions: Procedure: Diffusion tensor imaging MRI

• Registration Number: NCT03600636
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Study Start: 2018-12-07
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Diffusion tensor imaging MRI	-
antiphospholipid syndrome patients	Diffusion tensor imaging MRI	-

Primary Outcome Measures

Name	Time	Method
Mean diffusivity of white matter between groups	Day 0	mm2/s

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France