RecruitingNAINTERVENTIONAL

Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis

This research is investigating whether a combined PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging) scan can help doctors assess and manage cardiac sarcoidosis more effectively. Cardiac sarcoidosis is a condition where clumps of inflammatory cells form in the heart, which can be very serious. The study aims to see if this special scan can better predict how the disease will develop and if it will improve how doctors diagnose and treat patients. The goal is to better target treatments and potentially prevent serious complications like sudden death. Ultimately, the researchers hope that using PET/MRI will lead to better care for people with this heart condition.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

180

Start

07 Mar 2025

Estimated completion

07 Mar 2030

Cardiac Sarcoidosis

What is this study about?

This study is looking into a heart condition called cardiac sarcoidosis. It's when your body's immune system, which normally fights off infections, creates tiny clumps of cells (called granulomas) in your heart. These clumps can damage the heart and stop it from working properly. For people with sarcoidosis, heart problems are a big concern, sometimes even more so than lung problems.

Doctors are always looking for better ways to understand how cardiac sarcoidosis might affect a person, especially to find out who might be at risk of serious issues like a sudden heart problem. This study is testing if a special type of scan, called a PET/MRI, can help with this. It combines two powerful imaging techniques (PET and MRI) to get a very detailed picture of the heart. The researchers believe this combined scan could be much better at showing how the disease is progressing and helping doctors tell the difference between old scars and new active inflammation.

By using this advanced scan, the hope is that doctors can make more accurate diagnoses and choose the best treatments, like certain medications, or even consider devices that help the heart. Ultimately, this study aims to improve the care for people with suspected cardiac sarcoidosis, helping them live healthier lives.

Key takeaways

This study uses a special PET/MRI scan to better understand cardiac sarcoidosis.
It hopes to improve how doctors predict how the disease will affect patients.
The goal is to lead to better diagnosis and treatment choices.
Participants must be 18+ with suspected heart involvement from sarcoidosis.
There are specific health conditions and requirements for taking part.
Your doctor can help you decide if this study is right for you.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a diagnosis of sarcoidosis. Doctors would also need to suspect that your sarcoidosis is affecting your heart. This suspicion could come from symptoms like fainting, persistent heart flutters, or signs of heart failure. It could also be based on abnormal heart rhythms found during tests, or unusual findings on a heart ultrasound scan, like changes in the heart's size or how well it pumps.

There are also some reasons why you wouldn't be able to join. These include certain medical conditions like uncontrolled mental health issues, claustrophobia (fear of small spaces), or a known allergy to the dyes used in the scans. You also can't be pregnant or breastfeeding. If you have kidney problems, certain metal implants in your body (like some pacemakers or clips for brain aneurysms), or if you can't follow a special diet before the scan, you wouldn't be able to take part. Also, if you've had a heart attack in the past or have known coronary artery disease, this study might not be suitable for you.

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.

I am 18 years old or older.
I have been diagnosed with sarcoidosis, and my doctor suspects it might be affecting my heart.
I do not have severe claustrophobia.
I am not pregnant or breastfeeding.
I do not have certain types of metal implants or severe kidney problems.
I am able to follow a special diet and fast before the scan.

Answer every question to see your result.

What does participation involve?

The description here doesn't specify the exact number of visits, duration of follow-up, or if any medication is involved. However, it mentions scans and preparation. If you take part, you would likely need to undergo a special PET/MRI scan. Before the scan, you would need to follow a specific low-carbohydrate diet for 24 hours, followed by a 6-hour fast. During the scan, you'd need to be able to hold your breath for about 10 seconds. The full duration of the study for each participant isn't mentioned.

Potential risks and benefits

Taking part in research studies always has potential benefits and risks. A potential benefit of this study is that it could help improve how doctors diagnose and treat cardiac sarcoidosis in the future, ultimately leading to better care for patients. While the study itself does not offer direct medical treatment, the information gained might help your medical team better understand your condition. Potential risks include those associated with the PET/MRI scan, such as exposure to a small amount of radiation from the PET part of the scan, and potential allergic reactions to the contrast dyes (gadolinium for MRI, and fluoro-desoxyglucose for PET). Being in an MRI scanner can be uncomfortable for some, especially those with claustrophobia. You would be fully informed about these risks and benefits before deciding to participate, and importantly, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Henri Mondor Hospital
Verified postcode
Créteil, France· Recruiting

Common questions

What is cardiac sarcoidosis?

It's a condition where inflammatory cells form in your heart, which can cause damage and make it harder for your heart to work properly.

What is a PET/MRI scan?

It's a special type of scan that combines two powerful imaging techniques to get a very detailed picture of your heart, helping doctors see inflammation and damage.

Why is this study important?

It aims to find out if the PET/MRI scan can help doctors better predict how cardiac sarcoidosis will progress, leading to more accurate diagnoses and better treatment plans.

Will I get treatment by joining this study?

The study itself doesn't offer direct new treatments, but the information from your scans might help your doctors manage your condition better.

What do I need to do before the scan?

You'll need to follow a special low-carbohydrate diet for 24 hours and then fast for 6 hours before your PET/MRI scan.

How to find out more

Vania TACHER, PHD

vania.tacher@aphp.fr 01 49 81 29 29 Official trial record

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