RecruitingPHASE2INTERVENTIONAL

Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2

This study is investigating a condition called carotid stenosis, which is when the main arteries in your neck supplying blood to your brain become narrowed. This narrowing can lead to strokes. We're particularly interested in a protein called ficolin-2, which we think plays a role in inflammation within these narrowed arteries and in the brain. We want to see if checking the levels of ficolin-2 in your blood, along with special brain and artery scans (PET/MRI), can help us understand who is most at risk of having a stroke. The goal is to find better ways to identify these individuals so they can get the right treatment to prevent future strokes.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

13 Feb 2024

Estimated completion

31 Dec 2026

CAROTID STENOSIS

What is this study about?

When the main arteries in your neck, called carotid arteries, become narrowed, it's known as carotid stenosis. This can lead to a stroke if parts of the blockage break off and travel to the brain. While we know that severe narrowing increases the risk, the make-up of the blockage itself, often called 'plaque,' also plays a big part. Some plaques are more 'unstable' or 'vulnerable' and are more likely to cause problems.

Researchers believe that a protein called ficolin-2 is involved in the body's inflammatory response, especially in conditions like artery narrowing. They think that the levels of ficolin-2 in your blood might change depending on whether the plaque in your artery is just growing steadily, or if it's in a more dangerous state, like breaking apart. However, when someone has an acute stroke, both the plaque breaking down and the injury to the brain itself can affect ficolin-2 levels, making it harder to tell what's causing the change.

This study aims to get a clearer picture. We will look at people who have recently had a mini-stroke (TIA) or a stroke caused by carotid artery narrowing. We will measure the ficolin-2 levels in their blood and also use special scans called PET/MRI. These scans help us see inflammation in both the carotid arteries and the brain. By comparing these measurements, we hope to understand if ficolin-2 levels are more closely linked to inflammation in the artery plaque, inflammation in the brain, or both. This could eventually help doctors predict who is most at risk of a stroke and guide their treatment.

Key takeaways

The study investigates a protein called ficolin-2 in people with narrowed neck arteries (carotid stenosis).
It aims to understand if ficolin-2 levels can indicate stroke risk.
Participation involves a blood test and a special PET/MRI scan.
The research could lead to better ways of predicting and preventing strokes.
It is for people who have recently had a mini-stroke or a stroke.
You can withdraw from the study at any time without it affecting your medical care.

Who may be eligible?

This study is for adults aged 18 and over who have recently experienced a mini-stroke (TIA) or a stroke. To be considered, your mini-stroke or stroke must have happened within the last 48 hours and be caused by a narrowing of your carotid artery (between 50% and 99% blocked). We would need to confirm this narrowing with imaging tests you've already had, like an ultrasound or MRI scan.

There are several reasons why someone might not be able to join. This includes if you have serious inflammatory conditions, severe kidney problems, or certain active infections or cancers. You also can't take part if you've had a heart attack or major surgery recently (in the last 30 days). If you have a pacemaker, cochlear implant, or other metal in your body that prevents you from having an MRI scan, you wouldn't be able to join. The study is also not suitable for pregnant or breastfeeding women, or women of child-bearing age who are not using effective birth control.

Finally, if you are currently participating in another clinical trial that involves new medicines, have significant memory or thinking problems that prevent you from understanding the study, or don't have health coverage, you would not be able to participate.

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 recently had a mini-stroke (TIA) or stroke (within 48 hours)?
Was your mini-stroke or stroke caused by a narrowing in your neck artery (carotid stenosis of 50-99%)?
Do you have any severe conditions like active cancer, serious kidney problems, or active infections?
Do you have any metal in your body (like a pacemaker) that stops you from having an MRI scan?
Are you pregnant or breastfeeding, or a woman of child-bearing age not using effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your ficolin-2 levels checked through a blood test. You will also have a special scan called a PET/MRI, which involves receiving a small amount of a harmless substance that helps highlight inflammation in your carotid arteries and brain. This scan will likely take a couple of hours. We will also collect some information about your general health. The study involves collecting these measurements and will not require you to take any new medication or have any follow-up visits specifically for this research. The total duration of your participation in the study will be at the time of your hospital stay for the stroke or mini-stroke.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of stroke risk, which could improve future stroke prevention. While the direct benefit to you personally may be limited, your involvement helps advance medical knowledge. There are minimal risks associated with blood tests, such as slight bruising or discomfort. The PET/MRI scan involves a small amount of radiation, similar to other standard imaging tests, and potential reactions to the contrast dye are rare. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Service de Neurologie vasculaire / CarMeN U1060 INSERM Hôpital Neurologique Pierre Wertheimer - GHE
Verified postcode
Bron, France· Recruiting

Common questions

What is carotid stenosis?

It's a narrowing of the main arteries in your neck that supply blood to your brain, often caused by a build-up of fatty deposits (plaque).

What is ficolin-2?

Ficolin-2 is a protein in your blood that's involved in your body's immune system and response to inflammation.

Why is this study important?

It aims to help doctors better predict who is at higher risk of stroke so they can get the right preventative treatments.

What is a PET/MRI scan?

It's a special type of imaging scan that combines two techniques to look at both the structure of your arteries/brain and how active or inflamed certain areas are.

Will I get paid to participate?

The study information does not mention any payment for participation.

How to find out more

Laura MECHTOUFF

laura.mechtouff@chu-lyon.fr 4.27.85.67.47 Official trial record

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