Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2023-01-01
2025-07-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Women with pregnancy after index CeAD
Women who became pregnant at least once after first index CeAD
No interventions assigned to this group
Women without pregnancy after index CeAD
Women who did not became pregnant after first index CeAD
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Stefan T Engelter, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Stroke Unit Sanatorio Allende
Córdoba, , Argentina
Department of Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, Austria
Helsinki University Central Hospital
Helsinki, , Finland
Charité Universitätsmedizin, Centrum für Schlaganfallforschung
Berlin, , Germany
Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern
Munich, , Germany
Hadassah-Hebrew University Medical Center
Jerusalem, , Israel
Neurology Clinic, University of Brescia
Brescia, , Italy
Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
Mexico City, , Mexico
University Hospital Basel, Stroke Center
Basel, , Switzerland
University Hospital Zurich, Stroke Center
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Stefan T Engelter, MD
Role: primary
Sandro K Fischer
Role: backup
Other Identifiers
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PB_2016_00547; ko23Engelter2
Identifier Type: -
Identifier Source: org_study_id