Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death
时间窗: 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.
次要结局
- Number of participants with recurrent cervical artery dissection(From date of first CeAD until date of latest follow-up assessed up to 35 years)
- Number of participants with new ischemic stroke(From date of first CeAD until date of latest follow-up assessed up to 35 years)
- Number of participants with new hemorrhagic stroke(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)(At date of latest, individual follow-up assessed up to 35 years after first CeAD)