Predicting stroke risk using extracellular vesicles in TIA patients
Official title: PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
Run by Cwm Taf University Health Board (NHS) · NCT05645081 · Data updated 2026-11-12
This study is trying to see if certain tiny particles in the blood can help predict which patients who have had a Transient Ischemic Attack (TIA) are at higher risk for having a stroke later on.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Cwm Taf University Health Board (NHS) Government |
| Locations | 1 site (Merthyr Tydfil) |
| Status | Recruiting |
| Started | October 1, 2021 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | August 20, 2024 |
| Trial ID | NCT05645081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years who have been diagnosed with TIA and are prescribed antiplatelet drugs or anticoagulants.
✕Probably not a fit
Patients who do not have a diagnosis of TIA or those who are not on antiplatelet or anticoagulant therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify novel biomarkers that can predict the risk of stroke in patients who have experienced a Transient Ischemic Attack (TIA). By screening 300 TIA patients and following them for 12 months, the study will investigate the association between endothelial-derived extracellular vesicles and increased thrombotic risk. The goal is to determine if these biomarkers can reliably identify patients at the highest risk of subsequent strokes. This research is crucial as over 25% of ischemic stroke patients have had a prior TIA, and current predictive measures are lacking.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for patients at high risk of stroke.
How similar studies have gone: While the approach of using extracellular vesicles as biomarkers is innovative, similar studies have shown promise in identifying stroke risk, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
The inclusion criteria for phase 1 (initial patient recruitment) will be: 1. 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. 2. TIA confirmed patient has been prescribed antiplatelet drugs or anticoagulants. 3. Patients must be aged \> 18 years. 4. Patients are taking an ordinary diet by mouth. The inclusion criteria for phase 2 (patient representing with stroke) will be: 1. Radiological evidence, on CT and/or MR imaging of the brain of cerebral infarction, with or without secondary haemorrhage. 2. 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. 3. No further investigations are thought necessary to confirm or refute the diagnosis. 4. Patients must be aged \>18 years. 5. Patients must not be pregnant or breast feeding. 6. Patients are taking an ordinary diet by mouth. Exclusion Criteria The Exclusion criteria for phase 1 (initial patient recruitment) will be: 1. Inability to give consent. 2. Inability to feed by mouth. 3. Short life expectancy. 4. Pregnancy or breastfeeding. 5. Symptoms are readily explained by medical problems not involving focal cerebral ischaemia. The Exclusion criteria for phase 2 (patient representing with stroke) will be: 1. Patients who have not previously given consent for follow up blood sampling. 2. Patients who are unable to feed by mouth. 3. Patients in whom life expectancy is short. 4. Patient is pregnant or breast feeding.
Where it's running
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Prince Charles Hospital
Merthyr Tydfil, United Kingdom Recruiting
Study contacts
- Study coordinator: Jessica Williams, PhD
- Email: jwilliams3@cardiffmet.ac.uk
- Phone: 02920417077
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.