Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PLAQUE AND BRAIN INFLAMMATION IN SYMPTOMATIC CAROTID STENOSIS: ROLE OF THE FICOLIN-2 STATEMENT

This research is investigating the connection between a specific protein in the blood, called ficolin-2, and problems like inflammation in the brain and fatty deposits (known as plaque) in the carotid arteries. These are important blood vessels in your neck that supply blood to your brain. The study is focusing on people who have experienced a stroke or a 'mini-stroke' (transient ischemic attack, or TIA). The main goal is to see if the amount of ficolin-2 in your blood can tell us something about how much inflammation is in your brain or how much plaque is in your arteries, using special brain and artery scans. By understanding these links, doctors hope to learn more about preventing future strokes and improving treatments for those who have already had one. The study also looks at how these plaques are structured, including whether they contain bleeding or fatty areas.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hospices Civils De Lyon

Enrolment target

Start

08 Aug 2023

stroke or transient ischemic attack

What is this study about?

This study is about understanding what causes strokes and 'mini-strokes' (TIAs) better. When you have a stroke or TIA, it's often because a fatty deposit, called plaque, builds up in the arteries in your neck (carotid arteries) that supply blood to your brain. Sometimes, this plaque can become unstable, or parts of it can break off and travel to your brain, causing a stroke.

Researchers are particularly interested in a specific protein in your blood called ficolin-2. They want to see if the levels of this protein are connected to how much inflammation is happening in your brain or how much plaque is in your carotid arteries. To do this, they will take blood samples and use special scans, called PET/MRI scans, which can show inflammation and the makeup of these plaques and your brain tissue. These scans help them see things like the size of any brain damage and whether there's any leakage in the brain's blood vessels.

The overall aim is to find out if ficolin-2 could be a 'marker' – something that doctors can measure to understand your risk of stroke or the severity of your condition. This kind of research is really important because it could lead to new ways to predict, prevent, or treat strokes in the future. It’s an exploratory study, meaning they are looking for new information and connections to guide future research.

Key takeaways

This study investigates links between a blood protein (ficolin-2) and inflammation in the brain.
It focuses on people who have had a stroke or mini-stroke (TIA).
Special scans (PET/MRI) will be used to look at brain inflammation and artery plaques.
The goal is to improve understanding and potentially find new ways to prevent or treat strokes.
Participation involves blood tests and imaging scans on a few separate visits.
You won't get immediate personal health benefits, but your participation helps future patients.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. If you have experienced a stroke or a 'mini-stroke' (also known as a transient ischemic attack or TIA), you might be able to take part.

The research team will need to check other details about your health and medical history to make sure the study is a good fit for you and that it would be safe for you to participate. This check helps ensure the study results are clear and meaningful for everyone involved.

It's important to remember that not everyone who has had a stroke or TIA will be eligible, as there are often specific health criteria that need to be met for safety and research purposes.

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?
Have you had a stroke or a 'mini-stroke' (TIA)?
Are you able to attend appointments for blood tests and special scans?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would need to visit the study center on at least two separate occasions. On your first visit, you would have some blood tests to check your ficolin-2 levels. On your second visit, which might be about 5 days later, you would have another blood test and undergo special scans called PET/MRI. These scans involve receiving two different substances: gadoteric acid and 18F-DPA-714.

These substances help the PET/MRI scans show details about inflammation in your brain and the fatty plaques in your carotid arteries. In some cases, there might be a follow-up visit around 15 days later for additional blood tests. The exact number of visits and tests will be explained in detail by the study team, but it will involve blood draws and the specialised imaging scans. Your total time in the study will depend on the exact schedule, but includes the initial assessment, the PET/MRI scan, and any follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main benefit of this study is contributing to our understanding of strokes and TIAs, which could lead to better ways to prevent or treat them in the future. You may not personally benefit directly from taking part. Potential risks include discomfort or minor side effects from blood draws, and exposure to very small amounts of radiation from the PET/MRI scans, similar to what you might experience with other medical imaging. The doctors will explain any specific risks related to the substances used for the scans. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
France

Common questions

What is a 'mini-stroke' (TIA)?

A mini-stroke, or TIA, is like a stroke but symptoms usually last only a few minutes and don't cause permanent damage. It's a warning sign of a future stroke.

What are carotid arteries?

These are major blood vessels on each side of your neck that deliver blood from your heart to your brain.

What is ficolin-2?

Ficolin-2 is a protein found in your blood that plays a role in your body's immune system and how it responds to inflammation.

What is a PET/MRI scan?

It's a special type of imaging scan that combines two powerful technologies to look inside your body, helping doctors see both structure and activity, like inflammation.

Will taking part help my stroke now?

This study is for research to learn more about strokes in general. It's unlikely to directly change your current stroke treatment or provide you with immediate health benefits.