MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease progression
研究概览
简要总结
This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.
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
- 是
入选标准
- •Patient participating in the PRO-SVD cohort
- •Symptomatic intracranial hemorrhage
- •Written informed consent provided by patient or next-of-kin
- •No contraindications against MRI
排除标准
- •Patient unsuitable for MRI follow-ups (e.g. claustrophobia)
- •Patients unlikely to attend 1-year follow-up
- •For healthy controls
- •Inclusion Criteria:
- •Clinically healthy person ≥ 55 years
- •Written informed consent provided by the healthy control
- •No contraindications against MRI
- •Exclusion Criteria:
- •Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)
- •Pre-existing dementia, cognitive decline or disorder of the central nervous system.
结局指标
主要结局
Disease progression
时间窗: 24 months
Composite endpoint of a new, clinically symptomatic ischaemic or haemorrhagic event as defined by the treating physician and/or any increase in small vessel disease and/or cerebral amyloid angiopathy burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.
次要结局
- MRI-defined disease progression(24 months)
- Increase in perivascular space severity scale(24 months)
- Increase in number of SVD-attributable, ischaemic lesions(24 months)
- Functional outcome(24 months)
- New cognitive impairment(24 months)
- Increase in number of SVD-attributable, haemorrhagic lesions(24 months)
- Clinical, vascular outcome event(24 months)