Understanding cognitive decline after stroke and the impact of COVID-19

Rates, Risks and Routes to Reduce Vascular Dementia

Registry ID
ISRCTN18274006
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
Academic and Clinical Central Office for Research and Development (ACCORD)
Enrollment
2000
Start date
2018-09-25
Completion date
2024-09-01
Last update
2026-08-17

Conditions

Summary

Stroke

Detailed description

Current interventions as of 17/06/2020: Baseline assessment will record demographic, clinical, family history, education, socioeconomic, lifestyle and prestroke functioning (mRS), including non-testability in patients without capacity. Lab data (including BP, carotid Doppler, ECG, echocardiography where performed) will also be collected. Initial direct-to-patient cognitive assessment will use brief cognitive screening tools including delirium, fatigue, mood, apathy, and frailty. Informants will be asked about prestroke cognition. Routine bran imaging (CT or MRI) will be collected to classify the index stroke and pre stroke findings with standard tools. Bloods will be taken for analysis of genetics. Early follow up will be at 4-8 weeks post baseline assessment. Here the researchers will also assess cognition, fatigue, mood, apathy and health-related quality of life. Bloods will be taken for analysis of inflammatory markers and stored for future analysis. The researchers will also record if the patient has died or changed their place of residence. Annual follow-up will be conducted for a minimum of 2 years, maximum of four years by post or phone, using validated functional (mRS), recurrent vascular events, cognition, mood, apathy, fatigue, health-related quality of life assessments as above, from both participant and informant. The MRI DTI substudy will be conducted in a subsample of R4VaD at selected centres. Multimodal MRI scanning including DTI and additional blood pressure readings will be conducted once at either baseline assessment or early follow up and again at 1 year. An estimate of peak adult cognitive ability will be recorded at the first assessment. The COVID-19 substudy will evaluate the impact of the COVID-19 pandemic on patients presenting with stroke. Information on COVID-19 status, treatment, additional risk factors and relevant laboratory and or radiological investigations such as chest CT will be collected for all patients at baseline and 1 ye

Interventions

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

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

Locations

Related clinical trials

View on source registry