The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- New ischemic lesion on postoperative MRI
研究概览
简要总结
A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with an unruptured intracranial aneurysm undergoing treatment
排除标准
- •Arteriovenous malformation related intracranial aneurysm
- •Moyamoya-disease related intracranial aneurysm
- •Ruptured intracranial aneurysm
结局指标
主要结局
New ischemic lesion on postoperative MRI
时间窗: 1-3 days
Diffusion-Weighted Imaging lesion
次要结局
- Neurological symptom(3 months)
- Return to work(3 months)
- Functional outcome(3 months)
- Aneurysm occlusion on angiography(6mo - 5yrs)
- Patients with late rebleeding from the target aneurysm(up to 10 yrs)
- Epilepsy(up to 10 yrs)
- Dementia(up to 10 yrs)
- Other stroke than aneurysm bleed(up to 10 yrs)
研究者
Rahul Raj
Principal Investigator
Helsinki University Central Hospital