The Risk of Rupture or Growth in Patients With Small Unruptured Paraclinoid Aneurysm: Paraclinoid ANeurysm Prospectively Driven ObseRvational Analysis (PANDORA) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 682
- 试验地点
- 8
- 主要终点
- Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA
研究概览
简要总结
The optimal consensus concerning treatment of incidental small paraclinoid unruptured intracranial aneurysms (UIAs) remains controversial. The aim of this prospective study is to reveal the natural history of small paraclinoid UIAs with the goal of informing the treatment plan.
详细描述
A prospective observational study will be conducted in 13 Korean centers enrolling a consecutive series of 645 patients with small paraclinoid unruptured intracranial aneurysms (UIAs) from 2015 to 2017.
The investigators defined the cohort population as adults(20 years old or more) with small (less than 5mm) unruptured paraclinoid aneurysm. To determine the growth rate and risk factors, the angiographic features based on MRA or CTA(ex) size, arterial relationship, multiplicity)and the clinical characteristics (ex) age, hypertension (HTN), diabetes mellitus(DM), Hyperlipidemia, smoking) are recorded at initial visit, 1 year, 2years, 3years, and 5years.
The cumulative risk and the risk factors of aneurysmal rupture and growth will be analysed.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed small unruptured paraclinoid aneurysms who agreed to participate.
- •20years old or more
- •less than 5mm in maximum diameter
- •neurological status of patients should be satisfied with less than modified Rankin score 2 or more than 70 in Karnofsky performance score
排除标准
- •patients had previous subarachnoid hemorrhage that could be related to the rupture of paraclinoid aneurysm.
- •traumatic, infectious or dissecting aneurysms
- •fusiform aneurysms
- •aneurysms that related to other vascular disease or brain tumor
- •aneurysm that associated with the atherosclerotic change of a parent artery
结局指标
主要结局
Number of increased maximal diameter of enrolled paraclinoid aneurysms on follow up MRA or CTA
时间窗: within 5years after enrollment
If, the maximal diameter(in mm) of aneurysm which is measured by 1 neurosurgeon and 1 neuroradiologist on follow up MRA or CTA (1,2,3,5 year follow up) is 1.5 times bigger than on initial MRA or CTA, investigators will decide that the aneurysm is increased.
Number of rupture of enrolled paraclinoid aneurysms
时间窗: within 5years after enrollment
annual rupture rate
次要结局
- Number of participants with worsened modified Rankin scale score(within 5years after enrollment)
- Treatment(due to growth or rupture) rate of enrolled aneurysms(within 5years after enrollment)
- Mortality rate of enrolled patients(related to rupture of aneurysm or not)(within 5years after enrollment)
- Number of participants with worsened Karnofsky Performance Status scale(within 5years after enrollment)
研究者
Jeong Eun Kim
Professor
Seoul National University Hospital