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

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

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Syndrome
• Intervention / Treatment: Procedure: Diffusion tensor imaging MRI

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Procedure: Diffusion tensor imaging MRI; 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
Other: antiphospholipid syndrome patients	Procedure: Diffusion tensor imaging MRI; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean-Christophe Gris, MD, CHU Nîmes

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Antiphospholipid Syndrome; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Diagnostic Techniques, Neurological; Neuroimaging; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging; Diffusion Tensor Imaging
• Other Study ID Numbers: LOCAL/2018/JCG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No