RecruitingOBSERVATIONAL

Greater Manchester CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases

This study aims to understand why people with inflammatory conditions, such as rheumatoid arthritis, are more likely to develop heart and circulation problems. Researchers want to find new ways to spot these heart issues early using a combination of health information, blood tests, and scans. The goal is to improve how heart problems are prevented and treated in individuals living with inflammatory diseases. Participants will include patients with inflammatory conditions, people with heart disease without inflammatory conditions, and healthy volunteers. The study will collect health information, blood samples, and may involve imaging tests like MRI scans to gain a clearer picture of these complex health links.

At a glance

Status

Recruiting

Sponsor

University of Manchester

Enrolment target

325

Start

30 Sep 2024

Estimated completion

01 Sep 2032

Cardiovascular Diseases Rheumatologic Disease

What is this study about?

This research, called 'CARDIOvascular Pathology in Immune-Mediated Inflammatory Diseases', is looking into the connection between long-term inflammatory conditions (like rheumatoid arthritis or lupus) and heart and circulation problems. Over one million people in the UK have these inflammatory conditions, and sadly, heart disease is a significant risk for them. Even with modern treatments for inflammatory diseases, heart issues can still lead to serious health problems or even death.

Currently, we don't fully understand why some people with these inflammatory conditions develop heart problems and others don't, or why the severity can differ so much. This makes it difficult for doctors to identify who is most at risk early on, or how best to tailor treatments. This study aims to fill these knowledge gaps by carefully collecting and analysing information from patients over time. By doing so, researchers hope to develop better ways to predict and diagnose heart problems sooner in people with inflammatory conditions, leading to improved care in the future.

To achieve this, the study will look at various aspects of health, including medical history, routine heart scans, and blood tests. They also plan to collect blood and urine samples and conduct advanced imaging like MRI scans of the heart for some participants. By comparing this information across different groups – patients with inflammatory conditions, those with heart disease but no inflammatory condition, and healthy volunteers – the researchers hope to uncover vital clues about the underlying causes and progression of heart disease in people with inflammatory disorders.

Key takeaways

Investigating heart health in people with inflammatory conditions.
Aims to find early signs of heart problems to improve future care.
No new medications are involved in this study.
Includes existing health data, blood tests, and potentially advanced scans.
Compares patients with inflammatory conditions to healthy volunteers and those with only heart disease.
Participation could help improve understanding for future patients.

Who may be eligible?

You might be able to take part if you are an adult, aged 18 or over. This study is looking for several different groups of people. You could be considered if you have a clear diagnosis of an inflammatory condition, such as rheumatoid arthritis, and either have a risk of developing heart problems but no history of major heart events, have recently experienced a major heart event, or have a history of previous heart events alongside your inflammatory condition.

They are also looking for comparison groups. This includes adults who have heart disease but do not have an inflammatory condition, and adults who are generally healthy, meaning you have no known inflammatory condition or heart disease. All participants must be able to understand the study information and provide their consent to take part.

There are some reasons why you might not be able to participate. For example, if you are under 18 years old or cannot provide your informed consent. If you are considered for certain advanced imaging like an MRI scan, you would not be able to take part if you have a pacemaker, certain metal implants in your head or eye, are pregnant or breastfeeding, or have severe kidney problems.

Quick self-check

Are you 18 years old or over?
Do you have a diagnosed inflammatory condition (e.g., rheumatoid arthritis, lupus)?
Are you able to understand study information and give your consent?
Do you not have a pacemaker or certain metal implants if considering MRI scans?
Are you not currently pregnant or breastfeeding if considering MRI scans?
Do you not have severe kidney problems if considering certain MRI scans?

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, the researchers will collect information about your past and current health, and keep track of your health in the future. This will involve gathering details from your routine hospital notes, including any heart scans or blood tests you've had or will have as part of your normal care. You will also be asked to complete some health questionnaires at different times throughout the study.

Some participants may be asked if they’d like to join additional sub-studies. One sub-study involves providing blood and urine samples. Another sub-study may include one or more specialist imaging tests, such as an echocardiogram (an ultrasound scan of the heart), a Cardiovascular Magnetic Resonance Imaging (CMR) scan (a detailed MRI scan of the heart), or a Laser Doppler Imaging (LDI) scan (which looks at blood flow in tiny vessels). The total duration of your involvement will depend on which parts of the study you participate in and how long the researchers need to collect follow-up information about your health.

All participants will be recruited from specialist NHS centres, initially starting at Manchester University Hospitals.

Potential risks and benefits

Taking part in this study may not directly benefit your own health, but the information collected will be incredibly valuable for improving our understanding of heart conditions in people with inflammatory diseases. This could lead to better diagnosis and treatment for others in the future. While general health information and samples are routinely collected, specific study procedures like advanced imaging may have potential risks, which will be fully explained before you decide to take part. 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)

Manchester University NHS Foundation Trust
Manchester, United Kingdom· Recruiting

Common questions

What is an Immune-Mediated Inflammatory Disease (IMID)?

IMIDs are long-term conditions where your immune system mistakenly attacks healthy parts of your body, causing inflammation. Examples include rheumatoid arthritis and lupus.

Why is this study important?

It's important because people with inflammatory conditions are at higher risk of heart problems, and we need to find better ways to understand, diagnose, and treat these issues early on.

Will I have to take any new medication?

No, this study does not involve new medications. It focuses on collecting health information, samples, and imaging to learn more about your condition.

What is the commitment if I join?

You'll provide health information, potentially blood/urine samples, and complete questionnaires. Some might have special scans. The researchers will discuss the exact commitment with you.

Who is funding this research?

The study is supported by the NIHR Manchester Biomedical Research Centre and other health research grants, ensuring independent and robust research.

How to find out more

James Lawrence, MSc

james.lawrence@manchester.ac.uk +44 161 306 5679 Official trial record

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