RecruitingOBSERVATIONAL

IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION

This study aims to discover better ways to identify people at risk of heart problems, such as myocarditis or heart failure. We're using a special type of heart scan called an MRI (Magnetic Resonance Imaging) to look at tiny changes in heart tissue. By measuring these changes, we hope to improve how doctors understand heart health and predict future issues. We're particularly interested in people who may have had inflammation in their heart, possibly from infections like COVID-19. This research can help us work out what a ‘normal’ scan looks like and how these advanced scans can help doctors make more accurate diagnoses and treatment plans in the future.

At a glance

Status

Recruiting

Sponsor

Johann Wolfgang Goethe University Hospital

Enrolment target

6,000

Start

15 Nov 2016

Estimated completion

30 Jun 2030

Myocarditis Heart Failure Myocardial Fibrosis Vascular Inflammation Long COVID Syndrome

What is this study about?

Imagine your heart tissue has specific magnetic properties that can change when it's not well. This study uses a special type of scan called a Cardiac MRI (CMR) to measure these tiny changes. Think of it like taking a very detailed picture of your heart's magnetic signals. We're focusing on two specific measurements, called T1 and T2 mapping, because they can show us if there's damage or inflammation in the heart muscle, even before you might feel any symptoms.

The exciting part is that these measurements are quite new, and they can sometimes look different depending on the MRI machine used. This study is all about making sure we understand these measurements properly. We want to work out what a 'normal' T1 and T2 reading looks like, and how these readings connect to a person's overall heart health, their risk factors (like high blood pressure), and other heart scan results.

Ultimately, this research helps doctors better understand who might be at risk of heart conditions, including those who have had conditions like Long COVID, where the heart might have been affected. By getting a clearer picture of these early changes, we hope to help doctors predict and prevent serious heart problems more effectively for a wide range of patients.

Key takeaways

New study using special heart MRI scans to detect early heart changes.
Aims to improve prediction of heart problems, especially after exposures like COVID-19.
Looking for volunteers aged 18+ without known heart conditions.
Involves one heart MRI scan; no medication or extended follow-up.
Your participation helps advance medical knowledge for future patient care.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. You must be able to understand the study and agree to take part. Importantly, we are looking for people who do *not* have a known heart condition or a reason for a heart MRI scan from their doctor.

This is because we want to learn more about what normal heart scans look like, and how these new measurements appear in people who might have very early or 'hidden' heart changes, especially after things like a COVID-19 infection. So, if you're generally healthy and don't have a diagnosed heart issue, you might be a good fit.

However, you won't be able to join if you have any reasons why you can't have an MRI scan. This could include having certain metal implants in your body or if your doctor has advised against an MRI because of a specific health condition. We will also check if you can safely receive the special dye used in some MRI scans.

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?
Can you understand the study information and give your consent to take part?
Do you *not* have a diagnosed heart condition?
Have you recently had a COVID-19 infection or vaccination and are worried about your heart?
Do you *not* have any metal implants or other reasons that would prevent you from having an MRI scan?
Are you comfortable with the possibility of receiving a special dye during the MRI scan?

Answer every question to see your result.

What does participation involve?

The study involves having one or more special heart MRI scans. During the scan, you'll lie still on a bed that slides into the MRI machine, and there might be some loud noises, so you'll be offered ear protection. For some scans, you might receive a special dye, given through a small drip in your arm, to help us see your heart even more clearly. You won't need to take any medication specifically for the study. There are no follow-up visits after the scan, and the total duration of your involvement will be just the time it takes for the scan itself, which is usually around 30-60 minutes.

Potential risks and benefits

Taking part in this study could help improve how doctors understand and detect heart conditions in the future, even though there's no direct benefit to you personally. The main risks are those generally associated with an MRI scan, such as feeling anxious in the scanner or, very rarely, a mild reaction to the contrast dye. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital Frankfurt
Verified postcode
Frankfurt am Main, Germany· Recruiting

Common questions

What is a Cardiac MRI and why is it used?

A Cardiac MRI is a powerful scan that uses a strong magnet and radio waves to take detailed pictures of your heart. In this study, we use it to look at tiny changes in your heart tissue that can signal early problems.

Will I get my scan results?

Because this is a research study looking at new techniques, we won't be giving individual scan results. If anything unexpected or concerning is found during your scan, the research team will inform your doctor.

Is the MRI scan safe?

Yes, MRI scans are generally very safe. We will check carefully for any reasons why you shouldn't have one, such as certain metal implants. The contrast dye used in some scans is also very safe, but we'll ask about allergies or kidney problems first.

Do I have to do anything special before the scan?

You might be asked to avoid caffeine or certain foods before the scan, and we'll give you clear instructions beforehand. You should continue to take any regular medications unless advised otherwise by your doctor or the study team.

What happens if I change my mind?

You are free to change your mind and withdraw from the study at any time, without giving a reason. Your decision will not affect your relationship with your doctor or any future medical care.

How to find out more

Valentina O Puentmann

cvi-studien@unimedizin-ffm.de +4969 630184491 Official trial record

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