NCT05734378招募中不适用
Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Ischaemic stroke
研究概览
简要总结
Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.
The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
- •Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
- •Other SVD (i.e. CADASIL or other sporadic or genetic SVD)
排除标准
- •Life expectancy of <6 months due to not-SVD related causes (i.e. cancer)
- •Patient is unlikely to attend follow-up visits
结局指标
主要结局
Ischaemic stroke
时间窗: 1 year
Defined by CT and/or MRI
Cardio-vascular death
时间窗: 1 year
According to the treating physician
Intracerebral haemorrhage (ICH)
时间窗: 1 year
Non-traumatic, intracerebral haemorrhage (ICH, including convexity subarachnoid haemorrhage)
次要结局
- Functional outcome(1 year)
- Other intracranial bleeding(1 year)
- Other (transient) neurological attacks(1 year)
- New-onset of extracranial vascular disease(1 year)
- Cognitive impairment(1 year)
研究者
研究点 (1)
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