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

NCT03600636 | Completed

• 1 other identifier: LOCAL/2018/JCG-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antiphospholipid Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean diffusivity of white matter between groups

  mm2/s

  Day 0

Secondary Outcomes (5)

• Fractional anisotropy of white matter between groups

  Day 0

• Radial diffusivity of white matter between groups

  Day 0

• Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

  Day 0

• Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

  Day 0

• Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies

  Day 0

Study Arms (2)

Control

OTHER

Procedure: Diffusion tensor imaging MRI

antiphospholipid syndrome patients

OTHER

Procedure: Diffusion tensor imaging MRI

Interventions

Diffusion tensor imaging MRI PROCEDURE

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

Control; antiphospholipid syndrome patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (2)

• 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.

  PMID: 26201292 BACKGROUND

• Gris JC, Chea M, Bouvier S, Pereira FR. Antiphospholipid Antibodies in Mental Disorders. Semin Thromb Hemost. 2025 Jun;51(4):448-456. doi: 10.1055/s-0044-1788696. Epub 2024 Jul 24.

  PMID: 39047993 RESULT

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Jean-Christophe Gris, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 26, 2018
• Study Start: December 7, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (1)