Actively Recruiting
PREDICT-EV: Association of Extracellular Vesicles and Blood Clotting in Predicting Stroke After Transient Ischemic Attack
Led by Cwm Taf University Health Board (NHS) · Updated on 2024-08-20
360
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Cwm Taf University Health Board (NHS)
Lead Sponsor
C
Cardiff Metropolitan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to identify if a new biomarker related to blood clot risk, called endothelial derived extracellular vesicles, along with changes in blood clotting time, can predict which patients with a Transient Ischemic Attack (TIA) are most likely to have a stroke. The study focuses on TIA patients, as over 25% of ischemic stroke cases occur in people who previously had a TIA. Stroke is a leading cause of disability, and preventing strokes in high-risk patients is a national health priority. The study will follow 300 participants over 12 months, divided into four groups: healthy individuals without stroke or TIA history; people referred to TIA clinics but found not to have TIA; patients confirmed with TIA who did not have a stroke within 12 months; and patients with TIA who did have a stroke within 12 months. Researchers will monitor and compare changes in extracellular vesicle levels and prothrombin time in these groups to assess stroke risk. Participants will undergo blood tests to measure the biomarker and clotting time, with follow-up over three years to observe changes. The study collects clinical information and imaging results to confirm stroke or TIA diagnosis. Researchers will also track patient diet status and medication use. The main outcomes are changes in the extracellular vesicles and prothrombin time, which may help identify those at highest risk for stroke after TIA.
CONDITIONS
Brief Title
Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with or without a diagnosis of TIA confirmed by a stroke physician.
- Patients prescribed antiplatelet drugs or anticoagulants if diagnosed with TIA.
- Patients aged over 18 years.
- Patients able to eat a normal diet by mouth.
- Patients with radiological evidence of cerebral infarction (stroke) from specific causes.
- Patients not pregnant or breastfeeding.
You will not qualify if you...
- Inability to give consent.
- Inability to eat by mouth.
- Short life expectancy.
- Pregnancy or breastfeeding.
- Symptoms explained by other medical problems not involving brain ischemia.
- Patients without prior consent for follow-up blood sampling (stroke group).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months after initial diagnosis
Participants undergo diagnostic assessments to confirm or exclude transient ischemic attack (TIA) or stroke.
Visits as needed for diagnosis and confirmation
Duration - 3 years
Participants are monitored over time to evaluate changes in extracellular vesicles and blood clotting parameters related to stroke risk.
Follow-up visits over 3 years for blood sampling and assessments
Trial Site Locations
Total: 1 location
1
Prince Charles Hospital
Merthyr Tydfil, United Kingdom, CF479DT
Actively Recruiting
Research Team
J
Jessica Williams, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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