RecruitingOBSERVATIONAL

The Origin and Role of Thromboembolism in the Pathogenesis of Ischaemic Stroke

This research is investigating the role of blood clots in different types of stroke. Many strokes happen when a clot blocks a blood vessel in the brain, but sometimes it's hard to find where the clot came from or confirm it caused the stroke. For some strokes, like 'lacunar' strokes, it's even debated if clots play a part at all. We're using a new type of imaging scan called 18F-GP1 PET/CT. This scan uses a special tracer that lights up blood clots. We've seen it work well in previous studies for other clot-related conditions. Our goal is to use this advanced scan to pinpoint the source and role of clots in people who have experienced a stroke, including those where the cause is currently unknown (cryptogenic stroke). This could lead to a better understanding and care for stroke patients.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

120

Start

28 Feb 2023

Estimated completion

01 Aug 2026

Stroke PET Thrombosis

What is this study about?

When someone has an ischaemic stroke, it usually means a blood clot has blocked an artery in their brain. However, doctors often find it really hard to figure out exactly where that clot came from or even be sure that a clot was definitely the cause. Sometimes, a person has a stroke, and even after many tests, doctors can't find the reason – these are called 'cryptogenic' strokes. There are also discussions about whether blood clots are involved in certain less common types of stroke, like 'lacunar' strokes.

This study uses a new, advanced imaging technique to get a clearer picture. We have a special scan called 18F-GP1 PET/CT. This scan involves injecting a tiny amount of a special substance called a 'radiotracer' into your body. This tracer is designed to stick to blood clots and then light them up on the scan. We've already tested this tracer in other health conditions where clots are involved, like heart attacks, and it's been very good at finding them.

Our main aim is to use this powerful scanning tool to understand more about blood clots in people who have had a stroke. We want to find out where these clots come from and what role they play in different kinds of strokes, especially those where the cause isn't obvious. By identifying the source of clots more accurately, we hope to gain valuable insights that could eventually help doctors make better decisions about preventing future strokes and improving treatments.

Key takeaways

The study aims to understand how blood clots cause different types of stroke.
It uses a new scan (18F-GP1 PET/CT) to find and track blood clots in the body.
Focuses on strokes where the cause is unclear (cryptogenic stroke) and lacunar strokes.
Findings could help develop better ways to prevent and treat strokes.
Participation involves various scans and tests, but no new medication.
Your standard medical care will continue as normal throughout the study.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must also have had a recent ischaemic stroke – that means a stroke caused by a blood clot – within the last 21 days.

There are several reasons why someone might not be able to join. For instance, if you're unable to give your agreement in writing, or if you can't have the necessary scans because of medical reasons, like certain kidney conditions or if you have something in your body that makes an MRI scan unsafe. We also can't include women who might be pregnant.

Additionally, if you have a known allergy to the dyes used in some scans, or if taking part would delay an important surgery (like carotid endarterectomy), you wouldn't be able to join. We also can't include people who've had a bleeding stroke (a haemorrhagic stroke) or have serious other medical conditions that would make participating difficult.

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 older?
Did you have an ischaemic stroke (clot-related) within the last 21 days?
Are you able to agree to take part in writing?
Do you have any medical conditions that prevent you from having MRI or PET/CT scans?
Are you pregnant or could you be pregnant?
Do you have any severe allergies to medical dyes or study medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll undergo several medical tests and scans. These include a special new scan called 18F-GP1 PET/CT, where a small amount of a special substance is injected to highlight blood clots. You'll also have an echocardiogram with a special contrast injection (a heart scan), an MRI scan of your head, and heart monitoring (ECG). These tests help us gather detailed information about your stroke and potential clot sources. We'll be looking at you within 21 days of your stroke. The exact number of visits will depend on the tests, but they will be scheduled to fit around your ongoing care. There is no study medication involved, and you'll continue with your usual stroke treatment as advised by your doctors.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a more detailed understanding of your own stroke, which could help your doctors with your future care, though this is not guaranteed for every individual. You would also be contributing to important research that could help improve our understanding and treatment of stroke for many people in the future. Potential risks include those associated with medical scans, such as exposure to a small amount of radiation from the PET/CT scan, and reactions to contrast dyes or the radiotracer, though these are rare. There's also the time commitment involved. You are free to withdraw from the study at any time without giving a reason, and this would not affect your standard medical care.

Locations (1)

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

Clinical Research Facility
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is an ischaemic stroke?

An ischaemic stroke happens when a blood clot blocks a blood vessel that carries blood to the brain, cutting off the supply of oxygen and nutrients.

What is a cryptogenic stroke?

A cryptogenic stroke is when someone has a stroke, but doctors can't find a clear cause for it, even after doing many tests.

What is a PET/CT scan?

It's a special type of scan that uses a small amount of a radioactive substance to see how your body's cells are working, combined with a CT scan for detailed images of your body structures. In this study, it helps us find blood clots.

Will I get my scan results?

The information from your scans will be shared with your medical team to help with your ongoing care, and they will discuss relevant findings with you.

Will this study cure my stroke?

No, this is a research study to understand strokes better, not a treatment study. It won't cure your stroke, but it could help lead to new and better treatments in the future.

How to find out more

Beth Whittington, MD

bwhittin@ed.ac.uk 01312426200 Official trial record

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