The Predictive Value of Retinal Vascular Signs for Patients With Intracranial Artery Stenosis: A Prospective, Continuity Study, Cross-sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
Intracranial artery stenosis (ICAS) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the Asian population. However, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. This study aims to evaluate the predictive value of retinal vascular signs for intracranial artery stenosis (ICAS) and explore a new screening method.
详细描述
Intracranial atherosclerosis stenosis (ICAS) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the Asian population. Compared with the other stroke subtypes, patients with ICAS particularly the degree of stenosis≥50% had more severe stroke, stayed longer in the hospital and higher risk of recurrent ischemic events. However, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. Retinal imaging has great advantages including share the same embryological origin, anatomic features, and physiological properties with brain, non-invasive, easy to popularize, inexpensive and possess good economic benefits. Therefore, investigators design this study to assess the predictive value of retinal vascular signs for intracranial artery stenosis (ICAS) and hope to explore a new screening method.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accept TCD examination and fundus examination
- •Signed informed consent
排除标准
- •Non-atherosclerotic stenosis, such as arteritis, moyamoya disease, arterial dissection, vascular malformation, etc., which were clearly diagnosed.
- •Intracranial space-occupying lesions
- •Jugular vein and intracranial venous lesions
- •Patients with severe cardiac, hepatic, renal disease.
- •Life expectancy of less than 1 year due to co-morbid conditions.
- •Known pregnancy (or positive pregnancy test), or breast-feeding.
- •Pathological myopia fundus changes
- •Refractive medium turbidity affects fundus observation
- •Anterior macular membrane of both eyes
- •Papilledema, optic neuritis and optic neuropathy
- •Patients who have had internal eye surgery in the last six months (including fundus laser)
- •Previous history of internal eye trauma
- •Poor image quality of fundus and images
- •Any condition which, in the judgment of the investigator, might increase the risk to the patient.
结局指标
主要结局
Specificity
时间窗: 6 months
Number of true negatives /(number of true negatives + number of false positives)\*100
Negative predictive value
时间窗: 6 months
Negative predictive value = number of true negatives /(number of true negatives + number of false negatives)\*100
Positive predictive value
时间窗: 6 months
Positive predictive value = true positive cases /(true positive cases + false positive cases)\*100
Sensitivity
时间窗: 6 months
Number of true positives /(number of true positives + number of false negatives)\*100
次要结局
未报告次要终点
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University