Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

Stroke, Ischemic Clinical Trial

— PREDICT-EV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645081
• Other study ID #: CT/1245/281530/19/20
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: September 1, 2027

Study information

• Verified date: December 2022
• Source: Cwm Taf University Health Board (NHS)
• Contact: Jessica Williams, PhD
• Phone: 02920417077
• Email: jwilliams3[@]cardiffmet.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion criteria for phase 1 (initial patient recruitment) will be:

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.

The Exclusion criteria for phase 2 (patient representing with stroke) will be:

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Stroke, Ischemic
• Transient Ischemic Attack

Locations

Country	Name	City	State
United Kingdom	Prince Charles Hospital	Merthyr Tydfil

Sponsors (2)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)	Cardiff Metropolitan University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the endothelial derived extracellular vesicle population		3 years
Primary	Change in patient Prothrombin time		3 years