Stroke, IschemicNCT06085612
Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry
An observational study of Stroke, Ischemic and Stenosis, Carotid, run by University Hospital Olomouc at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stenosis, Carotid
- What is being tested?
- Automated retinal oximetry
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2023to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include patients examined in Neurosonological laboratory in Neurology department of University Hospital Olomouc,
Who may be able to join
- 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.
Who cannot join
- patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 775 20
Michal Kral, MD, +420 604 171 594, michal.kral@fnol.cz
Michal Kral, MD
About this study
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.
Read more
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.
- Conditions
- Stroke, Ischemic, Stenosis, Carotid
- Being tested
- Automated retinal oximetry
- Keywords
- automated retinal oximetry
- Medical subject headings
- Ischemic Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated retinal oximetryDiagnostic test
Non invasive standard examination on automated retinal oximetry.
| Study group | Role | What they receive |
|---|---|---|
| Internal Carotid Artery Stenosis | Group of patients with internal carotid stenosis detected via ultrasound examination. Receives: Diagnostic Test: Automated retinal oximetry | |
| Non stenotic Internal Carotid Artery | Group of patients without internal carotid stenosis on ultrasound examination. Receives: Diagnostic Test: Automated retinal oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2028
Secondary outcomes (1)
Correlation with MRI ischaemic lesions
with clinically symptomatic and asymptomatic carotid stenosis correlated to MRI findings of ipsilateral ischaemic lesions in the stenotic basin.
Measured: 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kral, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085612
- Sponsor's protocol ID
- NW24-06-00380
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polidar P, Paskova B, Karhanova M, Sin M, Dornak T, Schreiberova Z, Divisova P, Veverka T, Franc D, Sanak D, Kral M. Study protocol - Prospective case-control trial - Impact of significant carotid stenosis on retinal perfusion measured with automated retinal oximetry. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Mar;169(1):66-71. doi: 10.5507/bp.2023.052. Epub 2024 Jan 3.
PubMed 38192247
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry
- ClinicalTrials.gov ID
- NCT06085612
- Acronym / sponsor ID
- NW24-06-00380
- Conditions
- Stroke, Ischemic, Stenosis, Carotid
- Keywords
- automated retinal oximetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Carotid Artery Stenosis | – | Diagnostic Test: Automated retinal oximetryGroup of patients with internal carotid stenosis detected via ultrasound examination. |
| Non stenotic Internal Carotid Artery | – | Diagnostic Test: Automated retinal oximetryGroup of patients without internal carotid stenosis on ultrasound examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients examined in Neurosonological laboratory in Neurology department of University Hospital Olomouc,
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated retinal oximetryNon invasive standard examination on automated retinal oximetry. | Diagnostic test | Internal Carotid Artery Stenosis, Non stenotic Internal Carotid Artery |
Primary outcome
Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.
Time frame: 2028
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.
1 secondary outcome
Correlation with MRI ischaemic lesions
Time frame: 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 38192247Polidar P, Paskova B, Karhanova M, Sin M, Dornak T, Schreiberova Z, Divisova P, Veverka T, Franc D, Sanak D, Kral M. Study protocol - Prospective case-control trial - Impact of significant carotid stenosis on retinal perfusion measured with automated retinal oximetry. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Mar;169(1):66-71. doi: 10.5507/bp.2023.052. Epub 2024 Jan 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stenosis, Carotid, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Král, MD., Ph.D. (+420604171594, michal.kral@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry. (time frame: 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.