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INflammation and Small Vessel Disease Study

This study, called INSVD, is investigating the link between inflammation in the body and brain damage, as well as memory and thinking problems, in people with cerebral small vessel disease. This condition affects the small blood vessels in the brain. Researchers want to see if changes in a person's inflammation levels can predict future brain damage, measured by MRI scans, and a decline in their thinking abilities. It's an observational study, meaning researchers will monitor people over time without giving specific treatments. It's being conducted in both the UK and the Netherlands and is funded by heart health organisations.

At a glance

Status
Recruiting
Sponsor
University of Cambridge
Enrolment target
200
Start
10 Aug 2022
Estimated completion
31 Jul 2026

What is this study about?

The INSVD study is designed to help us understand more about a condition called cerebral small vessel disease (SVD). This condition affects the tiny blood vessels in your brain, and it's a common cause of strokes and problems with memory and thinking. Researchers in this study are particularly interested in whether inflammation, which is your body's natural response to injury or infection, plays a role.

They want to see if changes in the level of inflammation in your body can predict, or give an early warning, of damage to the 'white matter' in your brain. White matter is like the wiring system of the brain, and damage to it can affect how well your brain works. They'll be using special scans, called MRI scans, to measure this. The study will also look at how inflammation might affect your 'cognitive' abilities, which include things like your memory, attention, and problem-solving skills.

This study is important because understanding the connection between inflammation and SVD could help doctors find new ways to prevent or manage the condition in the future. It's a collaborative effort between researchers in Cambridge, UK, and Nijmegen, Netherlands, supported by leading heart health charities.

Key takeaways

  • This study investigates inflammation's role in brain damage and memory problems in cerebral small vessel disease (SVD).
  • It's an observational study, meaning no new treatments are given; researchers just monitor participants.
  • Data from MRI scans and cognitive tests will be collected over two years.
  • Participation helps further our understanding of SVD for future treatment development.
  • The study is a collaboration between UK and Dutch researchers, funded by heart health charities.

Who may be eligible?

To join this study, you would need to be 40 years old or older and have a diagnosis of cerebral small vessel disease. This usually means you've had a type of stroke called a lacunar stroke, or you have symptoms of memory or movement problems linked to SVD, which has been confirmed on an MRI scan.

There are also some reasons why you might not be able to join. For example, if you're unable or unwilling to give your consent, or if you have certain medical conditions that might interfere with the study. These include having a pacemaker or other metal in your body that prevents you from having an MRI scan, or if you've recently had a vaccination or infection with a fever.

Other reasons for not being able to participate include having another cause for your stroke (not SVD), other heart conditions, certain long-term immune conditions, kidney problems, or other diagnosed brain conditions like Alzheimer's or Parkinson's. If you have a serious illness that limits your life expectancy or a known genetic cause for your small vessel disease, you would also not be able to take part.

Quick self-check
  • Are you 40 years old or older?
  • Have you been diagnosed with cerebral small vessel disease?
  • Are you able to have an MRI scan safely (e.g., no pacemaker)?
  • Do you have good kidney function (eGFR not too low)?
  • Do you *not* have other specific major illnesses like Alzheimer's or Parkinson's?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be involved in what's called an "observational cohort study." This means researchers will monitor your health over time without giving you any specific treatments. You would attend appointments for assessments, which might include having MRI scans of your brain and tests to check your memory and thinking skills. You might also have blood tests. The study plans to follow participants over a two-year period. More detailed information about the exact number of visits and what each visit involves would be provided if you were suitable for the study and expressed interest.

Potential risks and benefits

Participating in this study might not offer direct personal benefits, but your contribution could greatly help researchers understand cerebral small vessel disease better. This could lead to improved diagnosis and treatment for others in the future. The risks involved are generally low, mainly related to the standard procedures like MRI scans and blood tests, which will be carefully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

  • Radboud University Medical Centre
    Nijmegen, Netherlands· Recruiting
  • University of Cambridge
    Cambridge, United Kingdom· Recruiting

Common questions

What is cerebral small vessel disease (SVD)?

It's a condition affecting the tiny blood vessels in your brain, which can lead to strokes and problems with memory and thinking.

What is inflammation?

Inflammation is your body's natural way of responding to injury or infection. Sometimes, long-term inflammation can cause problems.

What is an MRI scan?

An MRI scan uses powerful magnets and radio waves to create detailed pictures of the inside of your body, including your brain, without using X-rays.

Will I receive any new treatment in this study?

No, this is an observational study, which means researchers will be monitoring your health and collecting information, but you won't be given any new treatments or medicines as part of the study itself.

How long does the study last if I participate?

The study aims to follow participants for a period of two years.

How to find out more

Hugh S Markus

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

Interested in taking part?

Register your interest

Share your details and the research team for "INflammation and Small Vessel Disease Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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