Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry

Stroke, Ischemic Clinical Trial

Official title:

Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085612
• Other study ID #: NW24-06-00380
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: October 2023
• Source: University Hospital Olomouc
• Contact: Michal Král, MD., Ph.D.
• Phone: +420604171594
• Email: michal.kral[@]fnol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Large vessel carotid stenosis represent significant cause of ischaemic stroke. Indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. Mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases.

Aim: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. The investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. This could help broaden the indication spectrum for revascularisation treatment for carotid stenosis.

Methods: The investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. Study group will provide both stenotic vessels and non-stenotic vessels forming the control group. Patients with significant carotid stenosis will undergo an MRI examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters.

Statistics: Correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. Data will be statistically evaluated at the 5% level of statistical significance. Results will be then reevaluated with emphasis on MRI findings in the carotid basin.

Conclusion: This prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Study population will include patients examined in ultrasound laboratory in Neurology department of University Hospital Olomouc, regardless of incidental finding of stenosis, examination due to acute symptoms or regular checkup of known stenosis.

Exclusion Criteria:

• patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic
• Ischemic Stroke
• Stenosis, Carotid
• Stroke, Ischemic

Intervention

Diagnostic Test:
• Automated retinal oximetry
Non invasive standard examination on automated retinal oximetry.

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.	To establish whether arterio-venous difference in the stenotic basin increases with the severity of stenosis and/or these changes vary depending on the severity of stenosis.	2028
Secondary	Correlation with MRI ischaemic lesions	with clinically symptomatic and asymptomatic carotid stenosis correlated to MRI findings of ipsilateral ischaemic lesions in the stenotic basin.	2029