NCT06416371|Recruiting
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Sponsor study identifier
observational
40
1 country
1
Study Start
January 13, 2025
Actual (reported)Primary Completion
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2024
Actual (reported)May 16, 2024
Actual (reported)January 13, 2025
Actual (reported)February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Retinal vessel leakage by automated segmentation
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.
within one angiogram
Retinal vessel leakage by manual grading
The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale
within one angiogram
Baseline blood-brain barrier breakdown
Within one MRI scan
White matter hyperintensity (WMH) volume adjusted for brain volume
Within one MRI scan
Change in white matter hyperintensity (WMH) volume adjusted for brain volume
Difference in MRI scans up to 5 years prior
Fazekas score
Within one MRI scan
Change in Fazekas score
Difference in MRI scans up to 5 years prior
Intravenous injection of sodium fluorescein for angiography of retinal blood vessels
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adults \>18 years old with mild ischaemic stroke with a modified Rankin scale (mRS) greater or equal to 2 at recruitment presenting to Edinburgh/Lothian stroke services. For details see Clancy, et al (2021) Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. European Stroke Journal 6:81-88. https://doi.org/10.1177/2396987320929617
NHS Lothian
Edinburgh, United Kingdom
Clancy U, Garcia DJ, Stringer MS, Thrippleton MJ, Valdes-Hernandez MC, Wiseman S, Hamilton OK, Chappell FM, Brown R, Blair GW, Hewins W, Sleight E, Ballerini L, Bastin ME, Maniega SM, MacGillivray T, Hetherington K, Hamid C, Arteaga C, Morgan AG, Manning C, Backhouse E, Hamilton I, Job D, Marshall I, Doubal FN, Wardlaw JM. Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. Eur Stroke J. 2021 Mar;6(1):81-88. doi: 10.1177/2396987320929617. Epub 2020 Jun 5.
MacCormick IJ, Maude RJ, Beare NA, Borooah S, Glover S, Parry D, Leach S, Molyneux ME, Dhillon B, Lewallen S, Harding SP. Grading fluorescein angiograms in malarial retinopathy. Malar J. 2015 Sep 24;14:367. doi: 10.1186/s12936-015-0897-7.
First Submitted
January 15, 2024
First Posted
May 16, 2024
Study Start
January 13, 2025
Actual (reported)Primary Completion
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
PUFFINS Brain Health Study
Contact the study team to confirm eligibility.
Study Completion
February 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 4, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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