Cervical Artery Dissection, Pregnancy Complications
Conditions
Keywords
Ischemic Stroke, Hemorrhagic Stroke
Brief 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. 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.
Interventions
None listed
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with recurrent cervical artery dissection | From date of first CeAD until date of latest follow-up assessed up to 35 years | assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI, MRI angiography, CT, CT angiography, digital subtraction angiography and/or ultrasound) |
| Number of participants with new ischemic stroke | From date of first CeAD until date of latest follow-up assessed up to 35 years | assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT) |
| Number of participants with new hemorrhagic stroke | From date of first CeAD until date of latest follow-up assessed up to 35 years | Intracerebral hemorrhage or subarachnoid hemorrhage assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT) |
| Number of participants with death | 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) | At date of latest, individual follow-up assessed up to 35 years after first CeAD | The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
Countries
Argentina, Austria, Finland, Germany, Israel, Italy, Mexico, Switzerland, United States
Contacts
Primary ContactStefan T Engelter, MD
Backup ContactSandro K Fischer
Outcome results
None listed