Liverpool-Heart and BRain Project Stroke Cohort
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Liverpool
- Enrollment
- 1,655
- Locations
- 1
- Primary Endpoint
- Number of participants with incident stroke, transient ischaemic attack, atrial fibrillation, myocardial infarction and heart failure
Study Overview
Brief Summary
What research question is being addressed?
Can improve the prediction of adverse outcomes be improved for people following a stroke to optimise their treatment and care?
How is it of relevance and importance to patients and public?
Following a stroke, people are at a higher risk of developing certain conditions including heart failure, another stroke and atrial fibrillation, a type of irregular heart rhythm. In the proposed study, the investigators will look at factors which may increase a person's risk of such conditions following stroke. From this, the investigators will determine if risk scores for these conditions can be improved for people post-stroke. This could help doctors decide what treatments are best.
Who would be eligible?
All adults at participating hospitals who have had an ischaemic stroke (where the stroke is caused by loss of blood flow to the brain) or a transient ischaemic attack ('mini-stroke') confirmed by a stroke doctor. All patients will be asked to take part in the study, or their family members may be asked to provide advice on their behalf if the patient is unable to.
Where is the study being conducted?
At participating hospitals in England and Wales.
What will the participants undergo?
At the time of stroke, patients have a lot of information collected about their health, the investigators will copy information from patient's medical records about their health after they agree to take part in the study. Patients or their family members will also be asked to complete some additional brief questionnaires about their quality of life, wellbeing and fatigue. Some questionnaires such as for cognitive function are already collected for patients following a stroke, but where this information has not been collected, it will be collected for the study. The investigators will ask the patients if they can be contacted in 12-months to repeat the questionnaires and information collected about their health.
Detailed Description
Study purpose and design.
People with prior stroke are at a high-risk of incident adverse cardiovascular outcomes including heart failure, atrial fibrillation (AF), recurrent stroke and vascular cognitive impairment and dementia. However, there is a need to clarify the underlying risk factors for these outcomes specific to post-stroke populations. Extensive research has been conducted to identify individuals at high-risk of cardiovascular disease through the development of risk prediction models. This has led to the incorporation of risk models for cardiovascular disease into guidelines for clinical practice with an aim to improve patient-centred care and decision-making. Risk factors frequently incorporated in such models include age, male sex, hypertension, cholesterol, smoking, and diabetes mellitus. Although some risk prediction models have examined cardiovascular outcomes such as AF in people post-stroke, further research is needed to refine these models and make recommendations for implementation to clinical practice. Identifying precise risk prediction models for cardiovascular disease and cardiovascular-related complications in people post-stroke is needed to target screening for conditions (such as AF) and develop targeted intervention strategies specific to this population.
Quality assurance plan
Pseudo-anonymised data using the unique, non-identifiable participant ID will be collected in an electronic case report form using Research Electronic Data Capture (REDCap; https://www.project-redcap.org). The data entered in to REDCap for the first 20 patients recruited at each site will be remotely checked for completeness. The data entered onto REDCap will be checked against electronic medical records and paper questionnaires at selected sites.
Data checks
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years old
- •Current in-patient at a participating hospital the time of baseline data collection for recent ischaemic stroke confirmed by stroke physician or transient ischaemic attack confirmed by magnetic resonance imaging (MRI)
Exclusion Criteria
- •Inability to provide informed consent and no personal consultee available or personal consultee does not think the person would want to participate
- •Receiving palliative or end-of-life care
Outcomes
Primary Outcomes
Number of participants with incident stroke, transient ischaemic attack, atrial fibrillation, myocardial infarction and heart failure
Time Frame: 12 months
Incident stroke, transient ischaemic attack, atrial fibrillation, myocardial infarction and heart failure
Number of participants with incident cognitive impairment
Time Frame: 12 months
Cognitive impairment determined from Montreal Cognitive Assessment (MoCA) test results
Mortality
Time Frame: 12 months
All-cause mortality and mortality from cardiovascular causes
Number of participants with incident dementia
Time Frame: 12 months
Dementia determined from clinical diagnosis
Secondary Outcomes
No secondary outcomes reported