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

Intracranial Stenosis Clinical Trial

— RVS-ICAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05270746
• Other study ID #: RVS-ICAS
• Status: Not yet recruiting
• Start date: February 27, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: February 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD,PhD
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intracranial Stenosis

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin	XI Cheng District
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Fengtai District

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. Erratum in: JAMA Neurol. 2016 Apr;73(4):481. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Number of true positives /(number of true positives + number of false negatives)*100	6 months
Primary	Specificity	Number of true negatives /(number of true negatives + number of false positives)*100	6 months
Primary	Positive predictive value	Positive predictive value = true positive cases /(true positive cases + false positive cases)*100	6 months
Primary	Negative predictive value	Negative predictive value = number of true negatives /(number of true negatives + number of false negatives)*100	6 months