NHS Lothian
Edinburgh, United Kingdom
Location status: Recruiting
NCT Number: NCT06416371
The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are:
* Does retinal vessel leakage occur in cerebral small vessel disease? * If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally?
Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels.
Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Edinburgh, United Kingdom
Location status: Recruiting
Cerebral small vessel disease (SVD) is a common cause of stroke and dementia. The molecular causes are unclear, limiting new therapies. Breakdown of the blood-brain barrier (BBB) is characteristic and may damage brain tissue. However, specialist MRI scans to measure BBB breakdown are expensive and time-consuming.
In contrast, measuring leakage from retinal blood vessels is relatively simple. The blood-retina barrier is very similar to the BBB, and SVD is likely to damage retinal and brain blood vessels in the same way. If so, then retinal angiography could be used to study SVD pathogenesis and measure the effect of new treatments with much greater resolution and lower cost than MRI.
We have three aims:
We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 (MSS3).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous injection of sodium fluorescein for angiography of retinal blood vessels
Time frame: within one angiogram
The presence and severity of retinal vessel leakage will be measured for each eye in terms of change in pixel brightness over the duration of the angiogram.
Time frame: within one angiogram
The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale
Time frame: Within one MRI scan
BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium
Time frame: Within one MRI scan
This is measured from the most recent structural MRI scan
Time frame: Difference in MRI scans up to 5 years prior
This is measured by comparing the most recent structural MRI scan with the baseline structural MRI scan
Time frame: Within one MRI scan
This is measured from the most recent structural MRI scan
Time frame: Difference in MRI scans up to 5 years prior
This is measured by comparing the most recent structural MRI scan with the baseline structural MRI scan
Time frame: Within one MRI scan
BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium
Time frame: Within one MRI scan
BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium
Time frame: Within one MRI scan
BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium
University of Edinburgh
Other
Retinal Vessel Leakage in Cerebral Small Vessel Disease: a Sub-study of the Mild Stroke Study 3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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