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

Sponsor

Cwm Taf University Health Board (NHS) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05645081

Collaborator

Cardiff Metropolitan University (Other)

360

Enrollment

Location

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic Transient Ischemic Attack Coagulation Disorder

Study Design

Study Type:

Observational

Anticipated Enrollment :

360 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Healthy Control A group of participants with no previous symptoms or diagnosis of TIA or stroke.
Non-TIA Control A group of participants who were referred to TIA clinic with symptoms of a TIA, however, were subsequently confirmed as not suffering with a TIA.
TIA, non-stroke A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants did not suffer a stroke within 12 months of TIA diagnosis.
TIA, stroke A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants went on to suffer a stroke within 12 months of TIA diagnosis.

Outcome Measures

Primary Outcome Measures

Change in the endothelial derived extracellular vesicle population [3 years]
Change in patient Prothrombin time [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.