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

• Conditions: Intracranial Stenosis

• Registration Number: NCT05270746
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-26
• Study First Submitted QC: 2022-02-26
• Last Update Submitted: 2022-02-26
• Study Start: 2022-02-27
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08
• Primary Completion: 2022-06-26
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity	6 months	Number of true negatives /(number of true negatives + number of false positives)\*100
Negative predictive value	6 months	Negative predictive value = number of true negatives /(number of true negatives + number of false negatives)\*100
Positive predictive value	6 months	Positive predictive value = true positive cases /(true positive cases + false positive cases)\*100
Sensitivity	6 months	Number of true positives /(number of true positives + number of false negatives)\*100

Trial Locations

Locations (2)

Xuanwu hospital;Capital Medical University; 🇨🇳 Beijin, XI Cheng District, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Fengtai District, China