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

Antiphospholipid Syndrome Clinical Trial

— APS Follow Up  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600636
• Other study ID #: LOCAL/2018/JCG-01
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diffusivity of white matter between groups	mm2/s	Day 0
Secondary	Fractional anisotropy of white matter between groups	Value between 0-1	Day 0
Secondary	Radial diffusivity of white matter between groups	mm2/s	Day 0
Secondary	Mean diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aß2GP1 antiphospholipid antibodies	mm2/s	Day 0
Secondary	Fractional anisotropy of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aß2GP1 antiphospholipid antibodies	Value between 0-1	Day 0
Secondary	Radial diffusivity of white matter between controls vs subgroups with only anticardiolipin or Lupus anticoagulant and/or aß2GP1 antiphospholipid antibodies	mm2/s	Day 0