Cervical Artery DissectionLONG-RECAPNCT06258109
Risk of Recurrent CeAD After Pregnancy
An observational study of Cervical Artery Dissection and Pregnancy Complications, run by University Hospital, Basel, Switzerland at 12 sites in 9 countries.
Trial summary
Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data. Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Artery Dissection, Pregnancy Complications
- How many people
- 1,000 participants
- Where
- 12 sitesin 9 countries
- Study dates
- 1 Jan 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged ≥18 years with prior CeAD.
Who may be able to join
- female
- prior symptomatic cervical artery dissection (= index CeAD)
- at least one long-term follow-up visit (at least 6 months after the initial event)
- with information available on outcome events:
- recurrent dissection
- ischemic stroke
Show all 10Show fewer
- hemorrhagic stroke
- functional outcome assessed by mRS score
- with data on pregnancy after the initial event
- at least 18 years old at the initial event
Who cannot join
- Male patients
- Age <18 years
- No long-term follow-up available or long-term follow-up < 6 months after initial event
- No data on pregnancy after initial event available
Trial locations and contacts
12 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 9 countries
United States2 sites, 2 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Germany2 sites, 2 recruiting
- Recruiting
Charité Universitätsmedizin, Centrum für Schlaganfallforschung
Berlin, 10117
- Recruiting
Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern
Munich, 81377
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel, Stroke Center
Basel, 4031
Stefan T Engelter, MD, +41 61 326 41 30, stefan.engelter@felixplatter.ch
Sandro K Fischer, +41 61 328 47 84, sandrokevin.fischer@usb.ch
- Recruiting
University Hospital Zurich, Stroke Center
Zurich
Argentina1 site, 1 recruiting
- Recruiting
Stroke Unit Sanatorio Allende
Córdoba, X5000BFB
Austria1 site, 1 recruiting
- Recruiting
Department of Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Israel1 site, 1 recruiting
- Recruiting
Hadassah-Hebrew University Medical Center
Jerusalem, 91120
Italy1 site, 1 recruiting
- Recruiting
Neurology Clinic, University of Brescia
Brescia
Mexico1 site, 1 recruiting
- Recruiting
Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
Mexico City, 14269
About this study
Official title: Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.
Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers.
Primary endpoint: Primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.
Read the detailed description
Background: Cervical artery dissection (CeAD) is a leading cause of stroke in women of childbearing age. Among the population with an initial CeAD, about 9% show a recurrence event (a range from 0 to 25% has been reported). Recurrence of CeAD can occur for several years after the initial event. CeAD has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. Previous studies on this subject are either based on small sample sizes or lack long-term data.
Objective: The investigators want to determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.
Furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. The investigators will also investigate if women actively decided against another pregnancy due to the initial CeAD.
Methods: This study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. The data will be obtained through review of medical records and patient interviews. The study will include all women with any prior CeAD who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of CeAD.
Primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. Secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified Ranking scale.
Statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.
- Keywords
- Ischemic Stroke, Hemorrhagic Stroke
- Medical subject headings
- Pregnancy Complications, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with pregnancy after index CeAD | Women who became pregnant at least once after first index CeAD | |
| Women without pregnancy after index CeAD | Women who did not became pregnant after first index CeAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death
The composite outcome measure includes the following outcome measures during the follow-up: (i) occurence of recurrent cervical artery dissection (CeAD), (ii) occurrence of any ischemic stroke, (iii) occurrence of any hemorrhagic stroke, (iv) death.
Measured: From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary outcomes (5)
Number of participants with recurrent cervical artery dissection
assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI, MRI angiography, CT, CT angiography, digital subtraction angiography and/or ultrasound)
Measured: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with new ischemic stroke
assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)
Measured: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with new hemorrhagic stroke
Intracerebral hemorrhage or subarachnoid hemorrhage assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)
Measured: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with death
Measured: From date of first CeAD until date of latest follow-up assessed up to 35 years
Functional outcome as assessed by modified Rankin Scale (mRS)
The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: At date of latest, individual follow-up assessed up to 35 years after first CeAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2024
- Study completion1 Jul 2025 (estimated)
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 University Hospital, Basel, SwitzerlandThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan T Engelter, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258109
- Sponsor's protocol ID
- PB_2016_00547; ko23Engelter2
- Acronym
- LONG-RECAP
- Status last verified
- Dec 2024
- First submitted
- 11 Jan 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
- ClinicalTrials.gov ID
- NCT06258109
- Acronym / sponsor ID
- LONG-RECAP / PB_2016_00547; ko23Engelter2
- Keywords
- Ischemic Stroke, Hemorrhagic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 14 Feb 2024 (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.
Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.
Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers.
Primary endpoint: Primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.
Detailed description
Background: Cervical artery dissection (CeAD) is a leading cause of stroke in women of childbearing age. Among the population with an initial CeAD, about 9% show a recurrence event (a range from 0 to 25% has been reported). Recurrence of CeAD can occur for several years after the initial event. CeAD has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. Previous studies on this subject are either based on small sample sizes or lack long-term data.
Objective: The investigators want to determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.
Furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. The investigators will also investigate if women actively decided against another pregnancy due to the initial CeAD.
Methods: This study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. The data will be obtained through review of medical records and patient interviews. The study will include all women with any prior CeAD who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of CeAD.
Primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. Secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified Ranking scale.
Statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with pregnancy after index CeAD | – | –Women who became pregnant at least once after first index CeAD |
| Women without pregnancy after index CeAD | – | –Women who did not became pregnant after first index CeAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged ≥18 years with prior CeAD.
Key inclusion criteria (10 listed)
- female
- prior symptomatic cervical artery dissection (= index CeAD)
- at least one long-term follow-up visit (at least 6 months after the initial event)
- with information available on outcome events:
- recurrent dissection
Key exclusion criteria (4 listed)
- Male patients
- Age <18 years
- No long-term follow-up available or long-term follow-up < 6 months after initial event
- No data on pregnancy after initial event available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
The composite outcome measure includes the following outcome measures during the follow-up: (i) occurence of recurrent cervical artery dissection (CeAD), (ii) occurrence of any ischemic stroke, (iii) occurrence of any hemorrhagic stroke, (iv) death.
5 secondary outcomes
Number of participants with recurrent cervical artery dissection
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with new ischemic stroke
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with new hemorrhagic stroke
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
Number of participants with death
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
Functional outcome as assessed by modified Rankin Scale (mRS)
Time frame: At date of latest, individual follow-up assessed up to 35 years after first CeAD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Stefan T Engelter, MD principal investigator
University Hospital, Basel, Switzerland
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Artery Dissection and Pregnancy Complications, run by University Hospital, Basel, Switzerland at 12 sites in 9 countries.
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 10 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Switzerland, Argentina, Austria and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan T Engelter, MD (+41 61 326 41 05, stefan.engelter@felixplatter.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death (time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years). 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 13 Dec 2024.