A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 8
- 主要终点
- Symptomatic hemorrhage
研究概览
简要总结
The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage in adult patients with cerebral cavernous malformation with the goal of informing the treatment plan.
详细描述
Cerebral cavernous malformation Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cerebral cavernous malformation. If the patient had multiple cavernous malformations, index cavernous malformation would be enrolled. Index lesion will be determined according to the criteria.
- Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as follows)
- Previous bleed
- Brain stem location
- Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)
- Periventricular
- Largest
All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
- •18 years old or more
排除标准
- •Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
- •Patients who are accompanied by other serious medical problems
结局指标
主要结局
Symptomatic hemorrhage
时间窗: 5 year
hemorrhage due to rupture of cavernous malformation
次要结局
- All hemorrhagic event including radiologic rupture(5 year)
- Symptomatic hemorrhage(1 year)
- All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom(1 year)
研究者
Jeong Eun Kim
Professor
Seoul National University Hospital