Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

NCT ID: NCT05645081

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2027-09-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Control

A group of participants with no previous symptoms or diagnosis of TIA or stroke.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

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.

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardiff Metropolitan University

OTHER

Sponsor Role: collaborator

Cwm Taf University Health Board (NHS)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prince Charles Hospital

Merthyr Tydfil, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jessica Williams, PhD

Role: CONTACT

jwilliams3@cardiffmet.ac.uk

02920417077

Facility Contacts

Rhian Beynon, LLM

Role: primary

Rhian.Beynon@wales.nhs.uk

01443 443443 ext. 75627

Other Identifiers

CT/1245/281530/19/20

Identifier Type: -

Identifier Source: org_study_id