Predicting stroke risk using extracellular vesicles in TIA patients

PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

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
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cwm Taf University Health Board (NHS) (other gov)
• Locations: 1 site (Merthyr Tydfil)
• Trial ID: NCT05645081 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years who have been diagnosed with TIA and are prescribed antiplatelet drugs or anticoagulants.

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.

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 performed: While the approach of using extracellular vesicles as biomarkers is innovative, similar studies have shown promise in identifying stroke risk, indicating potential for success.

Eligibility 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 this trial is running

Merthyr Tydfil

• Prince Charles Hospital — Merthyr Tydfil, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Jessica Williams, PhD

Conditions: Stroke, Ischemic, Transient Ischemic Attack, Coagulation Disorder, Stroke Risk, Extracellular Vesicles, Pro-Thrombotic Risk