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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

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE December 7, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
Mean diffusivity of white matter between groups [ Time Frame: Day 0 ]
mm2/s
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03600636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Fractional anisotropy of white matter between groups [ Time Frame: Day 0 ]
    Value between 0-1
  • Radial diffusivity of white matter between groups [ Time Frame: Day 0 ]
    mm2/s
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Official Title  ICMJE Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter
Brief Summary The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Antiphospholipid Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • Control
    Intervention: Procedure: Diffusion tensor imaging MRI
  • antiphospholipid syndrome patients
    Intervention: Procedure: Diffusion tensor imaging MRI
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jean-Christophe Gris, MD 04.66.68.32.11 jean.christophe.GRIS@chu-nimes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03600636
Other Study ID Numbers  ICMJE LOCAL/2018/JCG-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Christophe Gris, MD CHU Nimes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP