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Contact Information:

Prof Joanna Wardlaw
+441313322943
Joanna.wardlaw@ed.ac.uk


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Be Part of Research - Trial Details - Studies of small vessel diseases: the mild stroke study 3
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Studies of small vessel diseases: the mild stroke study 3

Not Recruiting

Open to: All Genders

Age: Adult

Edinburgh

Medical Conditions

Cerebral small vessel disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Every year there are about 35,000 people in the United Kingdom who have a type of stroke, called ‘lacunar’ or ‘small vessel’ stroke. Cerebral Small Vessel disease is thought to be a major cause for this kind of stroke and also contributes to at least half of existing cases of dementia. Small vessel disease is caused by damage to the lining of the tiny blood vessels in the brain which stops them from functioning normally and can cause damage to the brain. Though there is no known cure for small vessel disease, it now looks possible that some of this damage may be reversible. These studies will help us understand what goes wrong with the small blood vessels in the brain so that we can find ways to prevent and treat small vessel disease.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Aug 2018 02 Dec 2021

Publications

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33817338/ (added 06/04/2021)2021 Interim results article in https://doi.org/10.1177/23969873211034932 Secondary outcome results abstract European Stroke Organisation Conference 2021 (added 29/03/2023)2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37814956/ (added 11/10/2023)2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39499872/ (added 06/11/2024)

What does the study involve?
This is a clinical study of patients who have had a recent stroke in Edinburgh, United Kingdom. Participants will have a brain scan as part of their usual clinical care at the time of index stroke. They will attend their first study visit within 3 months of their stroke diagnosis. At this visit, symptoms reported by the participant will be assessed in detail and they will be asked questions about their medical history, lifestyle (e.g. smoking) and typical eating, sleeping and exercise habits. They will have detailed tests of their thinking and memory. We will also use a small camera (like those found at some opticians) to take pictures of the blood vessels in the back of the eye and take blood and urine samples for detailed tests and genetic analysis to understand what affects blood vessel function and damages the brain. In some patients we will measure blood pressure (BP) for a 24-hour period using a mobile BP cuff worn on the arm.

During this visit, participants will also have a very detailed magnetic resonance (MRI) brain scan to find out about the function of the small blood vessels in the brain, for example subtle leakiness, or the ability to increase blood flow when more oxygen is needed. For a small part of the scan, the participant will wear a face mask that alternates between normal air and air with a small amount of added carbon dioxide for three minute intervals. For another part of the scan, participants will have a dye injected into a vein in the arm. This dye will circulate to the brain and the scanner measures any dye that may leak from the blood vessels.

Participants will be asked to attend a subsequent visit about 3 months after their first visit, and again 6 and 12 months later, and 3-4 years later. During these visits, the participants will be asked some questions about their symptoms, their recovery and thinking and memory. They will also have a 30-minute magnetic resonance brain scan. We will also measure BP and take pictures of the blood vessels in the back of the eye. At the 3-4 years visit, participants will be invited to provide a venous blood sample for genetic analysis and complete a questionnaire on their concerns and healthcare status. Two substudies will also be offered at this time point.

Where is the study run from?
Centre for Clinical Brain Sciences, Edinburgh (United Kingdom) and the UK Dementia Research Institute at the University of Edinburgh

When is the study starting and how long is it expected to run for?
August 2018 to August 2025

Who is funding the study?
The Fondation Leducq Network for the Study of Perivascular Spaces in Small Vessel Disease; UK Medical Research Council Dementia Research Institute; Row Fogo Charitable Trust, The Stroke Association, NHS Research Scotland, NHS Lothian Research and Development, University of Edinburgh

Who is the main contact?
Professor Joanna Wardlaw
joanna.wardlaw@ed.ac.uk


Every year there are about 35,000 people in the United Kingdom who have a type of stroke, called ‘lacunar’ or ‘small vessel’ stroke. Cerebral Small Vessel disease is thought to be a major cause for this kind of stroke and also contributes to at least half of existing cases of dementia. Small vessel disease is caused by damage to the lining of the tiny blood vessels in the brain which stops them from functioning normally and can cause damage to the brain. Though there is no known cure for small vessel disease, it now looks possible that some of this damage may be reversible. These studies will help us understand what goes wrong with the small blood vessels in the brain so that we can find ways to prevent and treat small vessel disease.

Who can participate?
Adults who have had a mild non-disabling stroke and are able to have an MRI scan.

You can take part if:



You may not be able to take part if:


1. Pregnant or breastfeeding women, women of childbearing age not taking contraception Acceptable contraception in women of childbearing age is a “highly effective” contraceptive measure as defined by the Clinical Trials Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion2. Contraindications to gadolinium contrast agent used for DCE MRI (e.g. renal impairment (eGFR <30 ml/min) – though patients may still participate in other parts of the study.3. Other major neurological or psychiatric conditions affecting the brain and interfering with the study design (e.g. multiple sclerosis).4. Other stroke risk factors requiring immediate intervention that would preclude involvement in the study (e.g. tight symptomatic carotid stenosis).5. Severe cardiac (including symptomatic heart failure) or respiratory disease.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Centre for Clinical Brain Sciences and the UK Dementia Research Institute at the University of Edinburgh
    Chancellors Building Little France Crescent
    Edinburgh
    EH16 4SB

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Prof Joanna Wardlaw
+441313322943
Joanna.wardlaw@ed.ac.uk



The study is sponsored by University of Edinburgh & NHS Lothian Academic and Clinical Central Office for Research and Development (ACCORD) and funded by Fondation Leducq; UK Dementia Research Institute; Mrs Gladys Row Fogo Charitable Trust; Chief Scientist Office, Scottish Government Health and Social Care Directorate; Stroke Association; NHS Research Scotland; NHS Lothian Research and Development Office.



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Read full details for Trial ID: ISRCTN12113543
Last updated 30 December 2024

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