PREDICT-EV, Identifying Novel Biomarkers to Predict Stroke Risk: A Nested, Case-controlled Clinical Trial Protocol <sup/>

Stroke is the second leading cause of death worldwide, with both the scale and impact growing annually. Over 25% of ischaemic stroke sufferers have previously had a transient ischaemic attack (TIA), allowing a unique window of opportunity to diagnose, treat and adapt modifiable cardiovascular risk factors. Despite this, clinical teams are limited by a lack of appropriate methodologies to identify TIA patients at greatest risk of stroke, outside of identifying common cardiovascular risk factors. PREDICT-EV adopts a two-pronged approach, looking both prospectively and retrospectively at novel characteristics in TIA patients who go on to suffer with a stroke. A prospective nested, case-controlled design will allow analysis of novel extracellular vesicles, coagulative risk and a host of informative cohort characteristics. Patients and controls will be followed over the duration of the study, with stroke as the primary clinical outcome. Retrospectively, the Secured Anonymised Information Linkage databank, UK, will provide population data to track coagulative risk in TIA patients who do and do not go on to suffer with a stroke over a 20-year period. We anticipate the identification of a suite of novel biomarkers for TIA patients at greatest risk of suffering a stroke to be vastly impactful on stroke prevention strategies.