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

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05281887
Collaborator
(none)
120
1
121
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between the Changes of Retinal Structure and Function and Ischemic Stroke
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jan 1, 2032

    Arms and Interventions

    Arm Intervention/Treatment
    ischemic stroke

    According to diagnostic criteria

    healthy control

    without any retinal diseases

    Outcome Measures

    Primary Outcome Measures

    1. Optical coherence tomography angiography (OCTA) [1year]

      Quantitatively analyzing the retinal microcirculation and structure in patients with ischemic stroke by using OCTA.

    2. Electroretinogram (ERG) [1year]

      The amplitude(μV) and implicit time(ms) of a-wave, b-wave and oscillatory potentials in dark-adapted and light-adapted.

    Other Outcome Measures

    1. Electroencephalogram(EEG) [1year]

      Collecting the electrical activity of cerebral cortex in patients with ischemic stroke, including the electroencephalogram frequency(Hz) and amplitude(μV) of δ-wave, θ-wave, α-wave and β-wave. In addition, the pattern of these waves will be observed to find the signatures of ischemic stroke.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Guangdong Provincial People's Hospital

    Investigators

    • Study Director: Qianli Meng, Guangdong Provincial People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05281887
    Other Study ID Numbers:
    • GDREC2020207H(R1)
    First Posted:
    Mar 16, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guangdong Provincial People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2022