RecruitingOBSERVATIONAL

Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke

This study, called PREDICT-EV, is exploring new ways to predict who is most likely to have a stroke after experiencing a mini-stroke (known as a Transient Ischemic Attack or TIA). Currently, there's no reliable way to tell which TIA patients are at the highest risk of having a full stroke. Researchers are investigating specific tiny particles in the blood, called extracellular vesicles, and how they affect blood clotting. They want to see if these particles and changes in clotting time can act as early warning signs for stroke. The study will follow 300 TIA patients over 12 months to better understand these connections and hopefully develop better tools to prevent strokes in the future.

At a glance

Status

Recruiting

Sponsor

Cwm Taf University Health Board (NHS)

Enrolment target

360

Start

01 Oct 2021

Estimated completion

01 Sep 2027

Stroke, Ischemic Transient Ischemic Attack Coagulation Disorder

What is this study about?

Each year in the UK, around 100,000 people have a stroke, making it a leading cause of disability. The good news is that about 90% of strokes can be prevented. A major concern is that over a quarter of people who have an ischaemic stroke (the most common type, caused by a blood clot) previously had a Transient Ischemic Attack, or TIA. A TIA is often called a 'mini-stroke' because it has similar symptoms but usually lasts only a few minutes and doesn't cause lasting damage. However, having a TIA significantly increases your risk of having a full stroke later on.

Currently, doctors don't have a reliable way to tell which TIA patients are most likely to go on to have a stroke. This study, called PREDICT-EV, aims to change that. Researchers are looking for 'novel biomarkers' – these are like early warning signs in the body that can help predict future health problems. Specifically, they are focusing on tiny packages released from cells called 'extracellular vesicles' and how they affect blood clotting. They believe that certain types of these vesicles might indicate an increased risk of blood clots forming, which could lead to a stroke.

The study will involve following 300 patients who have had a TIA for a year. The researchers will collect blood samples to measure these extracellular vesicles and check how quickly the blood clots. By doing this, they hope to discover if higher levels of these specific vesicles, and certain changes in blood clotting, can identify the TIA patients who are at the highest risk of having a stroke. The ultimate goal is to develop better ways to identify these at-risk individuals earlier, allowing for more targeted prevention strategies and potentially saving lives.

Key takeaways

Stroke is a leading cause of disability in the UK, but 90% are preventable.
Having a TIA ('mini-stroke') significantly increases stroke risk.
Current methods can't reliably predict stroke risk after a TIA.
This study is looking for new 'warning signs' in the blood (biomarkers) to better identify at-risk individuals.
The goal is to improve stroke prevention for thousands of people.
Participation involves providing blood samples and being followed for 12 months.

Who may be eligible?

This study is looking for two main groups of people. Firstly, they are recruiting adults over 18 who have recently been diagnosed with a mini-stroke (TIA) by a stroke specialist. To be included, you would also need to be able to eat and drink normally, and it's expected that you'd already be taking standard medication for TIA, like antiplatelet drugs (which help prevent blood clots) or anticoagulants.

The second group they're interested in are adults over 18 who have suffered a stroke that has been confirmed by brain scans (like CT or MRI). For this group, it's important that the stroke was caused by a blood clot, whether that clot came from the heart, a large blood vessel, or formed directly in the brain. Again, you would need to be able to eat and drink normally.

There are also some reasons why you might not be able to join. For both groups, you wouldn't be able to take part if you are pregnant or breastfeeding, unable to give your consent (agreement) to participate, or if doctors think you have a very short life expectancy. If your symptoms can be explained by other medical problems not related to stroke, you would also be excluded from the initial recruitment stage.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or over?
Have you recently been diagnosed with a mini-stroke (TIA) OR had a stroke confirmed by brain scans?
Are you able to eat and drink normally by mouth?
Are you NOT currently pregnant or breastfeeding?
Are you able to give your consent (agreement) to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing it will involve is providing blood samples. The study will follow you over 12 months. After your initial recruitment, you likely won't have specific clinic visits just for the study unless you experience a stroke. If you do go on to have a stroke during the study period, the researchers would then want to take further blood samples to compare with your initial ones. There are no new medications or treatments given as part of this study; it's purely observational, meaning researchers are looking at what naturally happens to participants. The total duration of your active involvement in terms of providing samples would depend on whether you have a stroke during the study, but the follow-up period is for 12 months.

Potential risks and benefits

Taking part in this study will not involve new treatments or medications, so the medical risks are minimal – mainly those associated with standard blood tests, such as slight bruising or discomfort at the injection site. You can choose to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care. The potential benefit to you personally is limited, as the study is focused on discovery rather than direct treatment. However, by participating, you will be contributing vital information that could lead to better ways of predicting and preventing strokes for future patients, which is a significant altruistic benefit to public health.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Prince Charles Hospital
Verified postcode
Merthyr Tydfil, United Kingdom· Recruiting

Common questions

What is a TIA?

A TIA, or Transient Ischemic Attack, is often called a 'mini-stroke'. It has similar symptoms to a full stroke but usually lasts only a few minutes and doesn't cause lasting brain damage. However, it's a serious warning sign that you're at higher risk of having a full stroke.

What are 'biomarkers'?

Biomarkers are measurable signs in your body, like certain substances in your blood, that can indicate a particular disease, infection, or your risk of developing a health problem. This study is looking for new biomarkers that could predict stroke risk.

Will I receive new treatment in this study?

No, this study does not involve any new treatments or medications. It's an 'observational' study, meaning researchers are just looking at existing medical information and blood samples to understand stroke risk better.

What is involved if I take part?

If you take part, you will be asked to provide blood samples. The researchers will then follow your health information over 12 months to see if specific factors in your blood can predict future stroke risk.

Who is funding this research?

The information provided about the trial doesn't specify the funding source, but medical research is often funded by government bodies, charities, or sometimes pharmaceutical companies.

How to find out more

Jessica Williams, PhD

jwilliams3@cardiffmet.ac.uk 02920417077 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.