Risk of Recurrent CeAD After Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Artery Dissection, Pregnancy Complications. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Austria, Finland, Germany +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- University of Utah — Salt Lake City
- University of Virginia — Charlottesville
Germany · 2 centers
- Charité Universitätsmedizin, Centrum für Schlaganfallforschung — Berlin
- Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern — Munich
Switzerland · 2 centers
- University Hospital Basel, Stroke Center — Basel
- University Hospital Zurich, Stroke Center — Zurich
Argentina · 1 center
- Stroke Unit Sanatorio Allende — Córdoba
Austria · 1 center
- Department of Neurology, Medical University of Innsbruck — Innsbruck
Finland · 1 center
- Helsinki University Central Hospital — Helsinki
Israel · 1 center
- Hadassah-Hebrew University Medical Center — Jerusalem
Italy · 1 center
- Neurology Clinic, University of Brescia — Brescia
Mexico · 1 center
- Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez — Mexico City
Identifiers
NCT: NCT06258109 · PB_2016_00547; ko23Engelter2