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

NCT ID: NCT05270746

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-27

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Intracranial Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Fengtai District, China

Site Status

Xuanwu hospital;Capital Medical University

Beijin, XI Cheng District, China

Site Status

Countries

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China

Central Contacts

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Xunming Ji, MD,PhD

Role: CONTACT

010-83199430

Yuan Gao, MD

Role: CONTACT

Facility Contacts

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Xuxiang Zhang, MD,PhD

Role: primary

010-67018510

Xunming Ji

Role: primary

+86-10-83198952

References

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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.

Reference Type BACKGROUND
PMID: 24135208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24481975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26747792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19407228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23165340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28057562 (View on PubMed)

Other Identifiers

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RVS-ICAS

Identifier Type: -

Identifier Source: org_study_id

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