The Liverpool Heart And bRain Project (L-HARP):Protocol for an Observational Cohort Study of Cardiovascular Risk and Outcomes Following Stroke

Stephanie L Harrison,1,2 Deirdre A Lane,1– 3 Benjamin JR Buckley,1,2 Kausik Chatterjee,4 Muath Alobaida,1,2,5 Emily Shipley,1,2 Gregory YH Lip1– 3 1Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool, UK; 2Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK; 3Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; 4Care of the Elderly Department, Countess of Chester Hospital NHS Foundation Trust, Chester, UK; 5Department of Basic Science, Prince Sultan Bin Abdulaziz College for Emergency Medical Services, King Saud University, Riyadh, Saudi ArabiaCorrespondence: Stephanie L Harrison, Liverpool Centre for Cardiovascular Science, University of Liverpool, 6 West Derby Street, Liverpool, L7 8TX, UK, Email stephanie.harrison@liverpool.ac.ukAbstract: Further research is needed to refine risk prediction models for adverse cardiovascular outcomes following stroke in contemporary clinical practice, such as incident atrial fibrillation (AF), recurrent stroke, and cognitive impairment and dementia. The aims of this study are to prospectively investigate cardiovascular outcomes and risk factors for incident cardiovascular disease in a post-stroke cohort, and to externally validate, refine and expand current risk prediction models for cardiovascular and cardiovascular-related outcomes. The study sample size was based on the development of post-stroke risk prediction models for AF and was calculated as 1222 participants. The study design is a multicentre, prospective, observational cohort study. Participants will be adult patients admitted for ischaemic stroke confirmed by stroke physician or transient ischaemic attack (TIA) confirmed by MRI. Routinely collected data will be used in addition to the completion of simple validated questionnaires by the participants. Follow-up will be undertaken 12-months from the date of admission to hospital, in addition to linkage to routinely collected follow-up hospitalisation and mortality data. The primary outcomes are cardiovascular outcomes (including incident AF, stroke, TIA and myocardial infarction) at 12-month follow-up, all-cause mortality and mortality from cardiovascular causes, and incident cognitive impairment and dementia. Secondary outcomes include changes in function, depression, anxiety, fatigue and quality of life. The study has received approval from the Health Research Authority Research Ethics Committee (21/WA/0209), and is registered on https://www.clinicaltrials.gov/ (Identifier NCT05132465). Recruitment for the study began in October 2021 with completion of recruitment at all participating centres anticipated by October 2022.Keywords: stroke, risk prediction, epidemiology, cohort study