RecruitingOBSERVATIONAL

Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts

This study aims to understand what happens to people after they've had a recent small stroke, known as a lacunar infarct. Researchers are collecting information from patients and looking at their scans and possibly genes. They want to find out why some people might have another stroke, or develop problems with memory, thinking, depression, or walking difficulties after this type of stroke. By following people over time, the study hopes to identify early signs or factors that predict these outcomes. Ultimately, this research could help doctors provide better care and support to patients recovering from lacunar strokes.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

500

Start

06 Jun 2018

Estimated completion

30 Aug 2027

Lacunar Strokes

What is this study about?

This study is focused on people who have recently experienced a specific type of stroke called a lacunar infarct. This is when a small blood vessel deep inside the brain becomes blocked, leading to a small area of brain damage. Researchers are keen to learn more about how these strokes affect people in the long run. They are particularly interested in understanding how a lacunar infarct might lead to changes in your memory and thinking, your ability to move around, or even your mood.

To do this, the study will collect detailed information from patients, including their medical history, brain scan results (MRI), and potentially genetic information. By following many patients over time, the researchers hope to identify specific patterns or factors that might predict who is more likely to develop certain problems after a lacunar stroke. These problems could include having another stroke, developing issues with memory and thinking that might affect daily life, feeling depressed, or having difficulty with walking.

The main goal of gathering all this information is to build a clearer picture of the journey for patients after a lacunar infarct. By understanding what happens and why, doctors might be able to offer more tailored advice, support, and even new treatments in the future, helping people recover better and live healthier lives after this kind of stroke.

Key takeaways

This study focuses on small strokes called lacunar infarcts.
It aims to understand long-term effects on memory, movement, and mood.
Participation involves sharing medical information and annual check-ups.
It's an observational study, meaning no new medicines are given.
The research hopes to improve future care for stroke patients.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a very recent small stroke. This stroke, called a lacunar infarct, must have happened within the last 15 days and be confirmed by a brain scan (MRI). The scan should show a small blockage in one of the brain's tiny blood vessels, and the problem it caused should be less than 20mm in size.

You should also be able to attend follow-up appointments and be covered by French national health insurance. Before you can join, you'll need to give your informed consent, which means you understand what the study involves and agree to take part.

However, some people won't be able to join. This includes if you already have dementia, have severe physical disabilities that make it hard to move around, have other serious health problems that would affect the study, or if you have a specific brain condition called leukoencephalopathy not caused by blood vessel issues. Also, if you have a severe mental health condition or cannot have an MRI scan, you won't be able to participate. Lastly, if you are unable to understand and agree to participate yourself, or if your family cannot give consent for you, you won't be included.

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 small stroke (lacunar infarct) in the last 15 days?
Was your stroke confirmed by a brain MRI scan?
Can you attend regular follow-up appointments?
Are you covered by French national health insurance?
Do you not have a prior diagnosis of dementia or severe disability?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide information about your health and medical history. You will also have a brain scan (MRI) if you haven't recently had one or if a new one is needed for the study. The study involves a period of follow-up, which means you will have scheduled visits and neurological check-ups once a year. These appointments help the researchers track your health, memory, and physical abilities over time. There are no new medications given as part of this study, as it focuses on observing your natural recovery and any changes that occur. The total duration of your participation will depend on the study's plan for long-term monitoring, but it involves annual evaluations.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information collected could help doctors better understand lacunar strokes and improve care for future patients. There are minimal risks involved, mainly related to privacy of your medical information, though all data will be kept confidential. You will have regular monitoring of your health as part of your normal care, and this study adds to that. 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)

Hôpital Lariboisière
Verified postcode
Paris, France· Recruiting

Common questions

What is a lacunar infarct?

It's a type of small stroke caused by a blockage in a tiny blood vessel deep inside the brain.

Will I receive new treatment in this study?

No, this study is about observing patients and collecting information, not testing new treatments or medications.

How long will I be involved in the study?

You will have annual check-ups and follow-up evaluations, meaning your involvement will be over several years to track long-term changes.

Do I need to be in France to participate?

Yes, as per the eligibility criteria, you need to be affiliated with the French national health insurance, meaning the study is for patients in France.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Eric JOUVENT, MD, PhD

eric.jouvent@aphp.fr 33 1 49 95 65 29 Official trial record

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