NCT05281887

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
68mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Dec 2021Jan 2032

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Expected
Last Updated

August 9, 2022

Status Verified

December 1, 2021

Enrollment Period

1.1 years

First QC Date

January 5, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

Ischemic Strokeretinal

Outcome Measures

Primary Outcomes (2)

  • Optical coherence tomography angiography (OCTA)

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

    1year

  • Electroretinogram (ERG)

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

    1year

Other Outcomes (1)

  • Electroencephalogram(EEG)

    1year

Study Arms (2)

ischemic stroke

According to diagnostic criteria

healthy control

without any retinal diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ischemic stroke

You may qualify if:

  • Patients with ischemic stroke

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Qianli Meng

    Guangdong Provincial People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Qianli Meng

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

March 16, 2022

Study Start

December 1, 2021

Primary Completion

December 31, 2022

Study Completion (Estimated)

January 1, 2032

Last Updated

August 9, 2022

Record last verified: 2021-12

Locations