Cervical Artery DissectionNCT04253535
Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium
An observational study of Cervical Artery Dissection, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Artery Dissection
- What is being tested?
- questionnaries
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2020to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Minors or adults under guardianship
- Intracranial artery dissection
- Traumatic or iatrogenic dissection
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies
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.
Read the detailed description
In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.
To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.
- Conditions
- Cervical Artery Dissection
- Being tested
- questionnaries
- Keywords
- Pregnancy, Puerperium Recurrence, Cervical artery dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnariesOther
Study on questionnaries
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of CAD during pregnancy, childbirth or puerperium
This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.
Measured: Day 0
Secondary outcomes (3)
To determine the absolute risk of recurrence of CAD in this population.
This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.
Measured: Day 0
To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.
This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.
Measured: Day 0
To study the reasons of absence of pregnancy after a history of CAD
This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Feb 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Artery DissectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253535
- Sponsor's protocol ID
- RC19_0267
- Status last verified
- Dec 2020
- First submitted
- 31 Jan 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies
- ClinicalTrials.gov ID
- NCT04253535
- Acronym / sponsor ID
- RC19_0267
- Conditions
- Cervical Artery Dissection
- Keywords
- Pregnancy, Puerperium Recurrence, Cervical artery dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.
To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Minors or adults under guardianship
- Intracranial artery dissection
- Traumatic or iatrogenic dissection
- Patient refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnariesStudy on questionnaries | Other | – |
Primary outcome
Recurrence of CAD during pregnancy, childbirth or puerperium
Time frame: Day 0
This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.
3 secondary outcomes
To determine the absolute risk of recurrence of CAD in this population.
Time frame: Day 0
To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.
Time frame: Day 0
To study the reasons of absence of pregnancy after a history of CAD
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
Related trials for Cervical Artery Dissection
RecruitingObservational study
Defining the Basis of Fibromuscular Dysplasia (FMD)
Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection
Not yet recruiting
Antithrombotic Treatment Strategies in Cervical Artery Dissection
Cervical Artery Dissection
RecruitingObservational study
Targeting Real World Usage In Stroke Treatment
Saccular and Fusiform Aneurysms, Pseudoaneurysm
Recruiting
Next Generation Sequencing Analysis of Patients with Spontaneous Dissection of Cervical Arteries
Dissection Carotid Artery, Dissection Arterial
RecruitingObservational study
Risk of Recurrent CeAD After Pregnancy
Cervical Artery Dissection, Pregnancy Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Artery Dissection, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of CAD during pregnancy, childbirth or puerperium (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.