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

August 8, 2022 updated by: Guangdong Provincial People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ischemic stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ischemic stroke
According to diagnostic criteria
healthy control
without any retinal diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical coherence tomography angiography (OCTA)
Time Frame: 1year
Quantitatively analyzing the retinal microcirculation and structure in patients with ischemic stroke by using OCTA.
1year
Electroretinogram (ERG)
Time Frame: 1year
The amplitude(μV) and implicit time(ms) of a-wave, b-wave and oscillatory potentials in dark-adapted and light-adapted.
1year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalogram(EEG)
Time Frame: 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.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

January 1, 2032

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC2020207H(R1)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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