Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current interventions as of 17/06/2020:
Baseline assessment will record demographic, clinical, family history, education, socioeconomic, lifestyle and prestroke functioning (mRS), including non-testa
Sponsors
Academic and Clinical Central Office for Research and Development (ACCORD)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 17/06/2020: 1. Patients aged 18 years and over 2. No upper age limit 3. No severity limit 4. Ischaemic or spontaneous haemorrhagic (non-traumatic, non-subarachnoid haemorrhage, non-AVM) stroke and transient ischaemic attack (TIA) 5. Expected to survive at least 12 weeks DTI substudy only 1. Estimated life expectancy >= 1 year 2. No contraindications to MRI 3. Patients with capacity to consent at baseline COVID-19 substudy: expected to survive 12 weeks is not an inclusion criterion. Previous inclusion criteria: 1. Patients aged 18 years and over 2. No upper age limit 3. No severity limit 4. Ischaemic or spontaneous haemorrhagic (non-traumatic, non-subarachnoid haemorrhage, non-AVM) stroke and transient ischaemic attack (TIA) 5. Expected to survive at least 12 weeks
Exclusion criteria
Exclusion criteria: 1. Inclusion criteria not met 2. Aneurysmal, traumatic or AVM-associated haemorrhage or subarachnoid haemorrhage 3. Stroke mimics such as brain tumours 4. Prior diagnosis of cognitive impairment or dementia is NOT an exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of cognitive impairment and dementia up to at least two years after stroke, measured using a seven-level ordered categorical scale compromising cognition (normal, impairment in one domain, impairment in two or more domains), dementia (mild, moderate, severe) and death. The outcome scale is driven by information from the Montreal Cognitive Assessment (MoCA), the Modified Telephone Interview for Cognitive Status (TICS-m), Modified Rankin Scale (MRS), Barthel Index, IQCODE, disposition (need for nursing care), and evidence of dementia (formal diagnosis, taking a cholinesterase inhibitor or memantine) or death. These outcomes are measured at baseline, 4-8 weeks, and annually for a minimum of 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/06/2020: Measured in all patients at baseline, 4-8 weeks and annually for a minimum of 2 years, maximum of 4 years: 1. Cognition is measured using; presence of memory of thinking problems: single question yes/no, Verbal Fluency phonemic (letter F, A, S, Montreal Cognition Assessment (MoCA), Trail Making A & B, Telephone Interview of Cognition Scale- modified (TICS-m), Letter digit coding, Consortium to Establish a Registry for Alzheimer’s Disease (CERAD), Boston naming test (BNT) and a clinical diagnosis of dementia (e.g. from a memory clinic) 2. Mood is measured using; Patient health questionnaire (PHQ-9 and PHQ-SADS); Generalised Anxiety Disorder (GAD), Zung depression scale (ZDS), Office National Statistics-4 (ONS-4) and a clinical diagnosis of depression Measured as part of DTI substudy at baseline, 4-8 weeks and 1 year: 3. Features of small vessel disease on MRI are measured using; mean diffusivity (MD) peak height; peak width of skeletonized mean diffusivity (PSMD), MD in normal appearing white matter, index stroke size, location, subtype; WMH volume, score; SVD score; brain volume loss and other metrics including composite measures of brain damage (e.g. brain age metric, brain health index) and others that emerge during the study 4. Peak adult cognitive ability is measured using the National Adult Reading Test (NART) 5. Additional blood pressure measures Measured as part of the COVID-19 substudy at baseline and 1 year: 1. Details of COVID-19 infection are measured using; clinical features of suspected COVID-19 infection; date of onset of symptoms; date and result of nasopharyngeal swap; antiviral treatment; NEWS score; level of respiratory support; relevant blood and imaging findings (e.g. chest CT) Previous secondary outcome measures: Measured at baseline, 4-8 weeks and annually for a minimum of 2 years, maximum of 4 years: 1. Cognition is measured using; presence of memory of thinking problems: single question | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed