The Predictive Value of Retinal Vascular Signs for Intracranial Artery Stenosis (RVS-ICAS)

Capital Medical University1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Intracranial Stenosis

Eligibility

Sex: ALLMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age≥35 2. Accept TCD examination and fundus examination 3. Signed informed consent Exclusion Criteria: 1. Non-atherosclerotic stenosis, such as arteritis, moyamoya disease, arterial dissection, vascular malformation, etc., which were clearly diagnosed. 2. Intracranial space-occupying lesions 3. Jugular vein and intracranial venous lesions 4. Patients with severe cardiac, hepatic, renal disease. 5. Life expectancy of less than 1 year due to co-morbid conditions. 6. Known pregnancy (or positive pregnancy test), or breast-feeding. 7. Pathological myopia fundus changes 8. Glaucoma 9. Refractive medium turbidity affects fundus observation 10. Anterior macular membrane of both eyes 11. Papilledema, optic neuritis and optic neuropathy 12. Patients who have had internal eye surgery in the last six months (including fundus laser) 13. Previous history of internal eye trauma 14. Poor image quality of fundus and images 15. Any condition which, in the judgment of the investigator, might increase the risk to the patient.

Locations (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Fengtai District, China

Xuanwu hospital;Capital Medical University

Beijin, XI Cheng District, China

Outcomes

Primary Outcomes

Sensitivity

Number of true positives /(number of true positives + number of false negatives)\*100

Time frame: 6 months

Specificity

Number of true negatives /(number of true negatives + number of false positives)\*100

Time frame: 6 months

Positive predictive value

Positive predictive value = true positive cases /(true positive cases + false positive cases)\*100

Time frame: 6 months

Negative predictive value

Negative predictive value = number of true negatives /(number of true negatives + number of false negatives)\*100

Time frame: 6 months

Central Contacts

Xunming Ji, MD,PhD

CONTACT

010-83199430 jixm@ccmu.edu.cn

Yuan Gao, MD

CONTACT

gychina163@163.com

Data from ClinicalTrials.gov

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