Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Ischemic, Transient Ischemic Attack, Coagulation Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
Overview
Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.
Primary outcome measures
- Change in the endothelial derived extracellular vesicle population [Time frame: 3 years]
- Change in patient Prothrombin time [Time frame: 3 years]
Eligibility criteria
The inclusion criteria for phase 1 (initial patient recruitment) will be:
- Patients with or without diagnosis of TIA made by a physician working in stroke medicine, sufficiently so to start post-TIA care or so that no further investigation is thought necessary to confirm or refute the diagnosis.
- TIA confirmed patient has been prescribed antiplatelet drugs or anticoagulants.
- Patients must be aged > 18 years.
- Patients are taking an ordinary diet by mouth.
The inclusion criteria for phase 2 (patient representing with stroke) will be:
- Radiological evidence, on CT and/or MR imaging of the brain of cerebral infarction, with or without secondary haemorrhage.
- The underlying mechanism of cerebral infarction is embolic from a cardiac source (e.g. atrial fibrillation), atherothromboembolic (from aorta or other large vessels in the neck) or in-situ thrombosis. No further investigations are thought necessary to confirm or refute the diagnosis.
- No further investigations are thought necessary to confirm or refute the diagnosis.
- Patients must be aged >18 years.
- Patients must not be pregnant or breast feeding.
- Patients are taking an ordinary diet by mouth. Exclusion Criteria
The Exclusion criteria for phase 1 (initial patient recruitment) will be:
- Inability to give consent.
- Inability to feed by mouth.
- Short life expectancy.
- Pregnancy or breastfeeding.
- Symptoms are readily explained by medical problems not involving focal cerebral ischaemia.
The Exclusion criteria for phase 2 (patient representing with stroke) will be:
- Patients who have not previously given consent for follow up blood sampling.
- Patients who are unable to feed by mouth.
- Patients in whom life expectancy is short.
- Patient is pregnant or breast feeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- Prince Charles Hospital — Merthyr Tydfil
Identifiers
NCT: NCT05645081 · CT/1245/281530/19/20