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

NCT05270746 | Unknown DMC

• 1 other identifier: RVS-ICAS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Intracranial Stenosis

Outcome Measures

Primary Outcomes (4)

• Sensitivity

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

  6 months

• Specificity

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

  6 months

• Positive predictive value

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

  6 months

• Negative predictive value

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

  6 months

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ophthalmic consultation center

You may qualify if:

• Age≥35
• Accept TCD examination and fundus examination
• Signed informed consent

You may not qualify if:

• Non-atherosclerotic stenosis, such as arteritis, moyamoya disease, arterial dissection, vascular malformation, etc., which were clearly diagnosed.
• Intracranial space-occupying lesions
• Jugular vein and intracranial venous lesions
• Patients with severe cardiac, hepatic, renal disease.
• Life expectancy of less than 1 year due to co-morbid conditions.
• Known pregnancy (or positive pregnancy test), or breast-feeding.
• Pathological myopia fundus changes
• Glaucoma
• Refractive medium turbidity affects fundus observation
• Anterior macular membrane of both eyes
• Papilledema, optic neuritis and optic neuropathy
• Patients who have had internal eye surgery in the last six months (including fundus laser)
• Previous history of internal eye trauma
• Poor image quality of fundus and images
• Any condition which, in the judgment of the investigator, might increase the risk to the patient.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Fengtai District, 100070, China

Location

Xuanwu hospital;Capital Medical University

Beijin, XI Cheng District, 100053, China

Location

Related Publications (6)

• 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.

  PMID: 24135208 BACKGROUND

• 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.

  PMID: 24481975 BACKGROUND

• 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.

  PMID: 26747792 BACKGROUND

• 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.

  PMID: 19407228 BACKGROUND

• 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.

  PMID: 23165340 BACKGROUND

• 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.

  PMID: 28057562 BACKGROUND

Central Study Contacts

Xunming Ji, MD,PhD

CONTACT

010-83199430; jixm@ccmu.edu.cn

Yuan Gao, MD

CONTACT

gychina163@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: February 27, 2022
• Primary Completion: June 26, 2022
• Study Completion: July 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)