Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

NCT05645081 | Recruiting

• 1 other identifier: CT/1245/281530/19/20
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Transient Ischemic Attack; Coagulation Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in the endothelial derived extracellular vesicle population

  3 years

• Change in patient Prothrombin time

  3 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Patients who have not previously given consent for follow up blood sampling.
• Patients who are unable to feed by mouth.
• Patients in whom life expectancy is short.
• Patient is pregnant or breast feeding.

Sponsors & Collaborators

• Cwm Taf University Health Board (NHS): lead
• Cardiff Metropolitan University: collaborator

Study Sites (1)

Prince Charles Hospital

Merthyr Tydfil, CF479DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jessica Williams, PhD

CONTACT

02920417077; jwilliams3@cardiffmet.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: October 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)