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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of first CeAD until date of latest follow-up assessed up to 35 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From date of first CeAD until date of latest follow-up assessed up to 35 years |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients aged ≥18 years with prior CeAD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan T Engelter, MD | Contact | +41 61 326 41 05 | stefan.engelter@felixplatter.ch | |
| Sandro K Fischer | Contact | +41 61 328 47 84 | sandrokevin.fischer@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Stefan T Engelter, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States | |
| University of Virginia |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
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| Number of participants with new ischemic stroke |
assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT) |
| 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) | From date of first CeAD until date of latest follow-up assessed up to 35 years |
| 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) | The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
| At date of latest, individual follow-up assessed up to 35 years after first CeAD |
| Recruiting |
| Charlottesville |
| Virginia |
| 22908 |
| United States |
| Stroke Unit Sanatorio Allende | Recruiting | Córdoba | X5000BFB | Argentina |
| Department of Neurology, Medical University of Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
| Helsinki University Central Hospital | Recruiting | Helsinki | Finland |
| Charité Universitätsmedizin, Centrum für Schlaganfallforschung | Recruiting | Berlin | 10117 | Germany |
| Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern | Recruiting | Munich | 81377 | Germany |
| Hadassah-Hebrew University Medical Center | Recruiting | Jerusalem | 91120 | Israel |
| Neurology Clinic, University of Brescia | Recruiting | Brescia | Italy |
| Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez | Recruiting | Mexico City | 14269 | Mexico |
| University Hospital Basel, Stroke Center | Recruiting | Basel | 4031 | Switzerland |
|
| University Hospital Zurich, Stroke Center | Recruiting | Zurich | Switzerland |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |