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

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ClinicalTrials.gov Identifier: NCT03600636
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




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



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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

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


Contacts
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Contact: Jean-Christophe Gris, MD 04.66.68.32.11 jean.christophe.GRIS@chu-nimes.fr

Locations
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France
CHU Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Jean-Christophe Gris, MD         
Sub-Investigator: Jean-Paul Beregi, MD         
Sub-Investigator: Fabricio Pereira, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean-Christophe Gris, MD CHU Nimes

Publications:
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03600636     History of Changes
Other Study ID Numbers: LOCAL/2018/JCG-01
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: November 2018

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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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Syndrome
Antiphospholipid Syndrome
Disease
Pathologic Processes
Autoimmune Diseases
Immune System Diseases