NCT04253535

Brief Summary

Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

January 31, 2020

Last Update Submit

December 1, 2020

Conditions

Cervical Artery Dissection

Keywords

PregnancyPuerperium RecurrenceCervical artery dissection

Outcome Measures

Primary Outcomes (1)

  • Recurrence of CAD during pregnancy, childbirth or puerperium

    This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.

    Day 0

Secondary Outcomes (3)

  • To determine the absolute risk of recurrence of CAD in this population.

    Day 0

  • To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.

    Day 0

  • To study the reasons of absence of pregnancy after a history of CAD

    Day 0

Interventions

questionnariesOTHER

Study on questionnaries

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Inclusion Criteria: * Extracranial carotid or vertebral dissection * Symptomatic dissection (with symptom onset within the last four weeks) * Spontaneous dissection * Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.

You may qualify if:

  • Extracranial carotid or vertebral dissection
  • Symptomatic dissection (with symptom onset within the last four weeks)
  • Spontaneous dissection
  • Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.

You may not qualify if:

  • Minors or adults under guardianship
  • Intracranial artery dissection
  • Traumatic or iatrogenic dissection
  • Patient refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Nantes, 44093, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 14, 2020

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

FR(1)