Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05645081

Acronym

PREDICT-EV

Enrollment

360

Registered

2022-12-09

Start date

2021-10-01

Completion date

2027-09-01

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, Stroke, Ischemic, Transient Ischemic Attack

Keywords

Stroke Risk, Transient Ischemic Attack, Extracellular Vesicles, Pro-Thrombotic Risk

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Change in the endothelial derived extracellular vesicle population	3 years
Change in patient Prothrombin time	3 years

Countries

United Kingdom

Contacts

Primary ContactJessica Williams, PhD

jwilliams3@cardiffmet.ac.uk02920417077

Outcome results