Clinical trial NCT05270746: The Predictive Value of Retinal Vascular Signs for Intracranial Artery Stenosis (RVS-ICAS)
Official title: The Predictive Value of Retinal Vascular Signs for Patients With Intracranial Artery Stenosis: A Prospective, Continuity Study, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Stenosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Ophthalmic consultation center

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 6 months
measure: Specificity
timeFrame: 6 months
measure: Positive predictive value
timeFrame: 6 months
measure: Negative predictive value
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Fengtai District
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
state: XI Cheng District
Study officials:
References:
citation: Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
citation: Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.
citation: Waters MF, Hoh BL, Lynn MJ, Kwon HM, Turan TN, Derdeyn CP, Fiorella D, Khanna A, Sheehan TO, Lane BF, Janis S, Montgomery J, Chimowitz MI; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial Investigators. Factors Associated With Recurrent Ischemic Stroke in the Medical Group of the SAMMPRIS Trial. JAMA Neurol. 2016 Mar;73(3):308-15. doi: 10.1001/jamaneurol.2015.4315.
citation: Famakin BM, Chimowitz MI, Lynn MJ, Stern BJ, George MG; WASID Trial Investigators. Causes and severity of ischemic stroke in patients with symptomatic intracranial arterial stenosis. Stroke. 2009 Jun;40(6):1999-2003. doi: 10.1161/STROKEAHA.108.546150. Epub 2009 Apr 30.
citation: London A, Benhar I, Schwartz M. The retina as a window to the brain-from eye research to CNS disorders. Nat Rev Neurol. 2013 Jan;9(1):44-53. doi: 10.1038/nrneurol.2012.227. Epub 2012 Nov 20.
citation: Cheung CY, Ikram MK, Chen C, Wong TY. Imaging retina to study dementia and stroke. Prog Retin Eye Res. 2017 Mar;57:89-107. doi: 10.1016/j.preteyeres.2017.01.001. Epub 2017 Jan 3.