Liverpool-Heart and BRain Project Stroke Cohort

NCT05132465 | Completed

• 1 other identifier: UoL001512
• Study Type: observational
• Target: 1,655
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Transient Ischemic Attack

Keywords

stroke; observational study

Outcome Measures

Primary Outcomes (4)

• Number of participants with incident stroke, transient ischaemic attack, atrial fibrillation, myocardial infarction and heart failure

  Incident stroke, transient ischaemic attack, atrial fibrillation, myocardial infarction and heart failure

  12 months

• Mortality

  All-cause mortality and mortality from cardiovascular causes

  12 months

• Number of participants with incident cognitive impairment

  Cognitive impairment determined from Montreal Cognitive Assessment (MoCA) test results

  12 months

• Number of participants with incident dementia

  Dementia determined from clinical diagnosis

  12 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from participating hospitals with a recent ischaemic stroke confirmed by stroke physician or transient ischaemic attack confirmed by MRI are eligible unless they are received palliative or end-of-life care. This study aims to be as inclusive as possible with recruitment and provide methods for advice to be sought from a personal consultee (relative/friend/carer) where informed consent is not possible in line with the Mental Capacity Act 2005.

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Countess of Chester Hospital

Chester, CH2 1UL, United Kingdom

Location

Related Publications (1)

• Harrison SL, Lane DA, Buckley BJR, Chatterjee K, Alobaida M, Shipley E, Lip GYH. The Liverpool Heart And bRain Project (L-HARP): Protocol for an Observational Cohort Study of Cardiovascular Risk and Outcomes Following Stroke. Vasc Health Risk Manag. 2022 Apr 26;18:313-318. doi: 10.2147/VHRM.S357829. eCollection 2022.

  PMID: 35502192 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Stephanie L Harrison, PhD

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 12, 2021
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: February 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)