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

Not Applicable

Conditions: Stroke
Circulatory System
Stroke, not specified as haemorrhage or infarction

Registration Number: ISRCTN18274006

Lead Sponsor: Academic and Clinical Central Office for Research and Development (ACCORD)

Brief Summary: 2024 Preprint results in https://doi.org/10.1101/2024.04.30.24306637 (added 21/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 2000

Inclusion Criteria

Current inclusion criteria as of 17/06/2020:
1. Patients aged 18 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 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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures