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

Primary Purpose

Antiphospholipid Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diffusion tensor imaging MRI
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Antiphospholipid Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control

antiphospholipid syndrome patients

Arm Description

Outcomes

Primary Outcome Measures

Mean diffusivity of white matter between groups
mm2/s

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2018
Last Updated
January 26, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03600636
Brief Title
Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Acronym
APS Follow Up
Official Title
Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Title
antiphospholipid syndrome patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Diffusion tensor imaging MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean diffusivity of white matter between groups
Description
mm2/s
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Fractional anisotropy of white matter between groups
Description
Value between 0-1
Time Frame
Day 0
Title
Radial diffusivity of white matter between groups
Description
mm2/s
Time Frame
Day 0
Title
Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
Description
mm2/s
Time Frame
Day 0
Title
Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
Description
Value between 0-1
Time Frame
Day 0
Title
Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aβ2GP1 antiphospholipid antibodies
Description
mm2/s
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Gris, MD
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26201292
Citation
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.
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Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

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