Cerebral small vessel disease Circulatory System Cerebrovascular disease, unspecified
Conditions
Interventions
Current interventions as of 27/08/2025:
Baseline visit (visit 1)
Participants will have their baseline visit within a maximum of three months following index stroke. During this visit, informed consen
Sponsors
University of Edinburgh & NHS Lothian Academic and Clinical Central Office for Research and Development (ACCORD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. History compatible with clinical lacunar stroke syndrome (LACS) and a recent, small subcortical infarct visible on diffusion MRI scan (+/- other sequences) or CT scan compatible with the clinical syndrome or if no subcortical infarct is visible and there is no other lesion present to explain the stroke symptoms. 1.1. Or a history of non-lacunar, minor (i.e. non-disabling) ischaemic stroke syndrome (PACS or POCS) and either a small cortical or striatocapsular or cerebellar +/- brainstem infarct visible on diffusion MRI (+/- other sequences) or if no acute infarct is visible and there is no other lesion to account for the symptoms. Participants with non-lacunar stroke will form the control group. 2. Age 18 years or older. 3. Ability to undergo MRI. 4. Capacity to give written informed consent. 5. Independent in activities of daily living (Modified Rankin score <3).
Exclusion criteria
Exclusion criteria: 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 occlusion 2. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of SVD lesions that regress, progress or appear de novo in the year after stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/08/2025: 1. BBB integrity as assessed using DCE-MRI brain scan at baseline visit. 2. CVR as determined by BOLD MRI brain scan response to hypercapnic challenge at baseline visit. 3. Intracranial vascular/CSF pulsatility as an index of rate of passage of pulse waves through the brain (stiffness) at baseline visit. 4. The incidence of recurrent stroke or transient ischaemic attack (TIA) and cardiac events. 5. Cognition including executive function, memory and visuospatial reasoning assessed using the MoCA at baseline and 3, 6 and 12 months. Incidence of mild cognitive impairment (MCI) and dementia 6. Neuropsychiatric and cognitive symptoms including apathy, fatigue, anxiety, depression, cognitive changes, informant-reported behavioural and cognitive change at baseline, 3, 6, and 12 months. 7. Change in function including strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation (Stroke Impact Scale measured at 6 and 12 months), manual dexterity assessment (9 Hole Peg Test measured at baseline) and gait assessment (Timed Up and Go measured at baseline and 12 months). 8. WMH, PVS, lacunes and microbleeds assessed individually and by SVD score using validated visual and computational methods at baseline, 3, 6, and 12 months. 9. White matter structural integrity measured with diffusion tensor parameters, water content (T1) and myelin (magnetisation transfer saturated) imaging methods at baseline, 6 and 12 months. 10. Life course factors including demographic, occupational and educational background measured at baseline. 11. Lifestyle factors including diet, sleep and smoking status assessed at baseline. 12. Brachial blood pressure at baseline, 3, 6, and 12 months and 24 hour Ambulatory Blood Pressure Monitoring (peak systolic, mean, diastolic arterial pressures pulse pressures, and variability) at baseline, 3 or 6 months in as many participants as possible. 13. Systemic | — |
Countries
Scotland, United Kingdom
Outcome results
None listed