NCT04363619已完成不适用
Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
研究概览
简要总结
Fundoscopy, optical coherence tomography (OCT) and OCT-angiography (OCTA) are established examinations and bear minimal risks. The recognition of retinal microvascular signs will enhance the pathophysiological understanding of the vasculopathy in patients with intracerebral haemorrhage (ICH) and aneurysmatic subarachnoid hemorrhage (aSAH) and might serve as prognostic and diagnostic indicators.
详细描述
The purpose of the study is to
- To evaluate the feasibility of fundoscopy, OCT and OCTA imaging in the environment of a Neurocritical Care Unit (NCCU)
- To detect, quantify and associate microvascular changes in the retina with signs of micro-vessel disease in ICH and DCI in aSAH
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All groups
- •Primary ICH or aSAH with symptoms onset < 3 days
- •18 to unlimited years of age
- •Signed informed consent obtained from legal representative or patient ICH group
- •Primary ICH localized either in basal ganglia, thalamus, pons or cerebellum aSAH group
- •Ruptured aneurysm visualized in contrast-enhanced computed tomography (angio-CT), MRI or cerebral angiography Control group
- •Stroke due to perimesencepahlic subarachnoid hemorrhage, arteriovenous malformation or isolated traumatic brain injury
排除标准
- •All groups
- •Cerebral amyloid angiopathy or other neurodegenerative disease
- •History of migraine with aura or ischemic stroke
- •Contraindication for pupil dilation (intracranial hypertension, allergy against mydriatics, angle closure glaucoma)
- •Any pre-existing or manifest ocular condition affecting either the integrity of retinal vessels, transparency of optical media or the risk of acute angle closure glaucoma
- •Concomitant instable critical illness (e.g. sepsis, multi-organ failure)
- •Intracranial pressure > 20mmHg and refractory to cerebrospinal fluid drainage
- •Pregnancy
结局指标
主要结局
i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.
时间窗: From hospital entry up to 3-6 months
次要结局
未报告次要终点
研究者
Emanuela Keller
Prof. Dr.
University of Zurich
研究点 (2)
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