Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCwm Taf University Health Board (NHS)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Inability to give consent.

Inability to feed by mouth.

Short life expectancy.

Pregnancy or breastfeeding.

Trial population

The sample will be selected from patients attending TIA clinic appointments, following primary care referral. Participants may also be identified from accident and emergency or following admission into hospital.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

360 Participants
are grouped into 4 trial groups
Group A: Healthy Control
Group B: Non-TIA Control
Group C: TIA, non-stroke
Group D: TIA, stroke

Trial outcomes

Primary outcomes

1

Change in the endothelial derived extracellular vesicle population

Time frame
3 years
2

Change in patient Prothrombin time

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cwm Taf University Health Board (NHS)

Lead sponsor

Cardiff Metropolitan University

Collaborator