Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416371
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-01-15
Brief Title:
Retinal Vessel Leakage in Cerebral Small Vessel Disease
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Retinal Vessel Leakage in Cerebral Small Vessel Disease a Sub-study of the Mild Stroke Study 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
1 Test the feasibility of fluorescein angiography in people with SVD
2 Discover if retinal vessel leakage occurs people with SVD
3 Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD
We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 MSS3
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
1 Test the feasibility of fluorescein angiography in people with SVD
2 Discover if retinal vessel leakage occurs people with SVD
3 Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD
We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 MSS3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None