Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281887
• Other study ID #: GDREC2020207H(R1)
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: January 2032

Study information

• Verified date: December 2021
• Source: Guangdong Provincial People's Hospital
• Contact: Qianli Meng
• Phone: 13926469923
• Email: mengqly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ischemic stroke is the most common type of stroke, accounting for 60%-80% of all types of strokes, and is one of the leading global causes of death and severe disability. In the risk factors of stroke, carotid atherosclerosis have higher incidence.As the only visible microvessels in vivo, retinal can provides an accurate window into cerebrovascular and systemic vascular conditions. Optical coherence tomography angiography (OCTA) and electroretinogram (ERG) can be used to quantitatively analyze the retinal structure and function in patients with ischemic stroke, and find out the valuable parameters. Electroencephalogram(EEG) can collect the electrical activity of cerebral cortex in patients with ischemic stroke and find the correlation between EEG and ERG. Finally, it is of great significance to establish a non-invasive, more objective, convenient and safe risk prediction model for stroke in combination with carotid atherosclerosis, retinal structural and functional parameters and EEG.

Description:

Firstly, this study will cross sectional analyze the retinal structure and function of patients with ischemic stroke to find the closely related parameters. Secondly, based on the results of cross section analysis, a cohort study will be established to build a risk prediction model for stroke combining carotid atherosclerosis, retinal structure and function parameters and EEG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2032
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with ischemic stroke

Exclusion Criteria:

• Refractive interstitial turbidity affect the examination results

• Any retinal diseases

• Other causes of ischemic stroke (cardiogenic embolism, dissection aneurysm, hemagglutination disorder, polycythemia, vasculitis, vascular malformation, etc.)

• Fails to complete an ophthalmic examination or the follow-up

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electroencephalogram(EEG)	Collecting the electrical activity of cerebral cortex in patients with ischemic stroke, including the electroencephalogram frequency(Hz) and amplitude(µV) of d-wave, ?-wave, a-wave and ß-wave. In addition, the pattern of these waves will be observed to find the signatures of ischemic stroke.	1year
Primary	Optical coherence tomography angiography (OCTA)	Quantitatively analyzing the retinal microcirculation and structure in patients with ischemic stroke by using OCTA.	1year
Primary	Electroretinogram (ERG)	The amplitude(µV) and implicit time(ms) of a-wave, b-wave and oscillatory potentials in dark-adapted and light-adapted.	1year