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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03600636
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Procedure: Diffusion tensor imaging MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Actual Study Start Date : December 7, 2018
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

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Arms and Interventions
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Arm Intervention/treatment
Control Procedure: Diffusion tensor imaging MRI
  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
antiphospholipid syndrome patients Procedure: Diffusion tensor imaging MRI
  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


Outcome Measures
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Primary Outcome Measures :
  1. Mean diffusivity of white matter between groups [ Time Frame: Day 0 ]
    mm2/s


Secondary Outcome Measures :
  1. Fractional anisotropy of white matter between groups [ Time Frame: Day 0 ]
    Value between 0-1

  2. Radial diffusivity of white matter between groups [ Time Frame: Day 0 ]
    mm2/s

  3. Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies [ Time Frame: Day 0 ]
    mm2/s

  4. Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies [ Time Frame: Day 0 ]
    Value between 0-1

  5. Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies [ Time Frame: Day 0 ]
    mm2/s


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600636


Locations
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France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean-Christophe Gris, MD CHU Nimes
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03600636    
Other Study ID Numbers: LOCAL/2018/JCG-01
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Disease
 Pathologic Processes
Autoimmune Diseases
Immune System Diseases