RecruitingOBSERVATIONAL

Fibrosis in Chronic and Delayed Myocardial Infarction

This study aims to understand how a process called fibrosis affects the heart in various conditions. Fibrosis means the heart muscle becomes scarred and stiff, which can happen after any heart injury. The researchers are particularly interested in patients with a narrowed heart valve (aortic stenosis), those who've had heart damage from chemotherapy, and people with a rare condition called carcinoid syndrome. They're using advanced imaging techniques, like PET-MRI scans with special tracing substances (68Ga-FAPI or 18F-AlF-FAPI), to find this scarring early on and see if it's actively changing. The goal is to learn more about how fibrosis develops and progresses in these heart problems.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

180

Start

10 Nov 2022

Estimated completion

31 Aug 2028

Aortic Stenosis Chemotherapy Induced Systolic Dysfunction Carcinoid Syndrome

What is this study about?

Imagine your heart is a strong, healthy muscle. Sometimes, due to illness or injury, it can develop scar tissue, much like a scar on your skin. This internal scarring in the heart is called 'fibrosis'. If too much scar tissue builds up, it can make the heart stiff and less able to pump blood effectively.

This research study wants to understand this fibrosis better in three specific heart conditions. The first is aortic stenosis, where one of the heart's main valves narrows, making the heart work harder. The second is heart damage that can sometimes occur after chemotherapy treatments for cancer. The third is a rare condition called carcinoid syndrome, which can also affect the heart's valves and lining.

The researchers are using special scanning techniques, called PET-MRI or PET-CT, with unique tracing substances (you might hear them called 68Ga-FAPI or 18F-AlF-FAPI). These tracers help highlight areas of active fibrosis in the heart on the scans. By doing this, they hope to detect fibrosis early, see how it changes over time, and learn if finding it early can help predict how someone's heart condition might progress. This information could eventually lead to better ways of diagnosing and treating these heart problems.

Key takeaways

This study investigates scar tissue (fibrosis) in the heart.
It focuses on aortic stenosis, chemotherapy heart damage, and carcinoid syndrome.
Researchers use special scans (PET-MRI/CT) to detect fibrosis early.
The goal is to better understand how fibrosis develops and affects heart health.
Participation involves scans and blood tests.
It may help improve future diagnosis and treatment for heart conditions.

Who may be eligible?

This study is looking for both men and women across different groups of people.

For those with a heart valve condition called aortic stenosis, they are looking for people over 50 with varying levels of narrowing (mild, moderate, or severe), as well as a small group with aortic sclerosis (a thickened valve without actual blockage). They also need healthy volunteers over 50.

If you've had chemotherapy, they're looking for men and women over 35 who show signs of heart problems from anthracycline treatment at least a year ago, or those who haven't shown such signs. Healthy volunteers over 35 are also needed. Finally, for the rare condition called carcinoid syndrome, they're looking for 30 patients over 35, whether or not their heart is currently affected.

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 able to freely give your consent to take part?
Are you at least 35 years old (or 50 for some specific groups)?
Do you have one of the conditions being studied: aortic stenosis, heart issues from chemotherapy, or carcinoid syndrome (or are a healthy volunteer)?
Are you able to lie still for an MRI scan?
Are you not pregnant or breastfeeding?
Do you have good kidney function (eGFR above 30 mL/min/1.73m2)?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves isn't fully provided, but it would include undergoing specific imaging scans (PET-MRI or PET-CT) which use special tracing substances. You would also have blood tests at different times during the study. If you have aortic stenosis, researchers might track changes before and after a valve replacement if you have one. The total duration of participation and the number of visits are not specified, but the study mentions tracking changes at 'different time-points'. You would also need to provide your informed consent before any procedures.

Potential risks and benefits

Taking part in a study like this could help doctors understand heart conditions and fibrosis better in the future, potentially leading to improved diagnosis and treatment for many people. However, there are some risks; for example, you would be exposed to a small amount of radiation from the PET scans, and there are standard risks associated with MRI scans, such as lying still in an enclosed space for a period. There's also a small chance of an allergic reaction to the contrast dye used in some scans. You are always free 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.

University of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is fibrosis?

Fibrosis is like scarring in the heart muscle. It can make the heart stiff and less able to work properly if it builds up too much.

What are PET-MRI and PET-CT scans?

These are special medical scans that combine different imaging technologies to get very detailed pictures of your heart, helping doctors see where fibrosis might be active.

What is a 'tracing substance'?

It's a tiny, safe amount of a special substance given before a scan that helps highlight specific areas, like fibrosis, making them visible on the images.

Who can't take part in this study?

People who are pregnant or breastfeeding, have severe kidney problems, a known allergy to scan dyes, or have certain metal implants that prevent an MRI can't join. You also can't join if you can't tolerate lying still for an MRI scan.

Will I get any treatment in this study?

This study is focused on understanding and diagnosing fibrosis, not providing a specific treatment. Any treatment you need for your heart condition would continue separately under your usual care.

How to find out more

Krithika Loganath, MBBS

kloganat@ed.ac.uk 07774365798 Official trial record

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