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

The Predictive Value of Retinal Vascular Signs for Patients With Intracranial Artery Stenosis: A Prospective, Continuity Study, Cross-sectional Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05270746
Acronym
RVS-ICAS
Enrollment
1000
Registered
2022-03-08
Start date
2022-02-27
Completion date
2022-07-01
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Stenosis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity6 monthsNumber of true positives /(number of true positives + number of false negatives)\*100
Specificity6 monthsNumber of true negatives /(number of true negatives + number of false positives)\*100
Positive predictive value6 monthsPositive predictive value = true positive cases /(true positive cases + false positive cases)\*100
Negative predictive value6 monthsNegative predictive value = number of true negatives /(number of true negatives + number of false negatives)\*100

Countries

China

Contacts

Primary ContactXunming Ji, MD,PhD
jixm@ccmu.edu.cn010-83199430
Backup ContactYuan Gao, MD
gychina163@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026