NCT05052788

Brief Summary

The aim of the study is to: - detect changes in retinal structure and microvasculature in patients with cerebral small vessel disease using optical coherence tomography angiography , correlate these changes with brain imaging markers and determine if ( OCTA ) can be used as a screening tool for cerebral small vessel disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 13, 2021

Last Update Submit

September 24, 2021

Conditions

Cerebral Small Vessel Disease and OCT Angio

Outcome Measures

Primary Outcomes (1)

  • Detection of retinal microvasculature changes using OCT angio (OCTA).

    OCTA can detect five parameters: ( macular vessel density, macular thickness, ganglion cell layer thickness, pericapillary nerve fiber layer thickness and pericapillary vessel density ). Compare between case and control group using OCTA parameters then correlate OCTA parameters with clinical and neurological imaging parameters.

    Anticipated 2 months

Study Arms (2)

Case group

40 patients according to inclusion criteria .

Device: Optical coherence tomography angiography

Control group

20 normal people with no history of previous brain insult and with free neurological examination .

Device: Optical coherence tomography angiography

Interventions

Optical coherence tomography angiographyDEVICE

OCT-A detects the motion of blood using intrinsic signals to capture the location of blood vessels. Despite its insensitivity to leakage and the relatively small field of view, the development of OCT-A has the potential to improve our knowledge of the physiology and pathophysiology of the eye. MRI as a stroke protocol, including T1 and T2 weighted images, diffusion weighted images (DWI), fluid attenuated inversion recovery (FLAIR), magnetic resonance angiography (MRA), and gradient recalled echo (GRE) T2\* weighted images, using a machine 1.5 tesla General Electric machine .

Also known as: MRI
Case groupControl group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two groups of people, patients (case group) and (control group), both groups are frequency matched in age and sex.

You may qualify if:

  • Patients diagnosed clinically with small vessel disease and verified by MRI.
  • must be at age of 50 or more.

You may not qualify if:

  • large vessel disease or non-ischemic leukoencephalopathy.
  • Patients with any type of cerebral haemorrhage .
  • Diabetic patients .
  • concurrent retinal diseases as epiretinal memberane and macular degeneration.
  • Past history of retinal operation or ocular surgery except for cataract surgery.
  • An history of glaucoma or optic neuropathy.
  • hematological diseases and coagulopathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cannistraro RJ, Badi M, Eidelman BH, Dickson DW, Middlebrooks EH, Meschia JF. CNS small vessel disease: A clinical review. Neurology. 2019 Jun 11;92(24):1146-1156. doi: 10.1212/WNL.0000000000007654. Epub 2019 May 29.

    PMID: 31142635BACKGROUND

  • Chen X, Wang J, Shan Y, Cai W, Liu S, Hu M, Liao S, Huang X, Zhang B, Wang Y, Lu Z. Cerebral small vessel disease: neuroimaging markers and clinical implication. J Neurol. 2019 Oct;266(10):2347-2362. doi: 10.1007/s00415-018-9077-3. Epub 2018 Oct 5.

    PMID: 30291424BACKGROUND

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sara Mohammad Gaber Mahmoud

CONTACT

01122240327Drsaramohammad33@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 22, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09