Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05645081

Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Charles Hospital

Merthyr Tydfil, CF479DT, United Kingdom

Location status: Recruiting

Location contact

Rhian Beynon, LLM

CONTACT

[email protected]

01443 443443 ext. 75627

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

  • 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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Williams, PhD

CONTACT

[email protected]

02920417077

Sponsors and collaborators

Lead sponsor

Cwm Taf University Health Board (NHS)

Other Gov

Collaborators

  • Cardiff Metropolitan University

Registry information

Official study title

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

Acronym: PREDICT-EV

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2022
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.