Active not recruitingOBSERVATIONAL

CMR-AI and Outcomes in AS

This study is looking at how a special computer program, called Artificial Intelligence (AI), can help doctors understand and treat a heart condition called aortic stenosis. Aortic stenosis is when one of the heart's valves narrows. We're using AI to analyse detailed heart scans (CMR scans) taken before people have their faulty heart valve replaced. The AI can measure tiny changes in the heart's pumping action that are hard for humans to see. We want to find out if these early changes, picked up by AI, can show us who might have problems, like needing to go to the hospital, within two years after their valve operation. This information could help doctors decide the best time to do the operation, personalising treatment for each patient.

At a glance

Status

Active not recruiting

Sponsor

Medical University of Vienna

Enrolment target

1,500

Start

01 Jan 2020

Estimated completion

01 Feb 2027

Aortic Stenosis

What is this study about?

Imagine your heart is a house with several rooms and doors. Aortic stenosis is like having a sticky, narrow door from your main pumping chamber (the left ventricle) going out to your body. This makes your heart work much harder. Doctors often use special scans called CMR (Cardiac Magnetic Resonance) to get very detailed pictures of your heart, similar to an advanced MRI scan just for your heart. These scans show the size, shape, and how well your heart is pumping.

Traditionally, a human expert looks at these scans, which can take time and sometimes small details might be missed. This study uses a new computer program, powered by Artificial Intelligence (AI), developed right here in the UK. This AI is super-efficient and very precise. It can automatically measure things like how much blood your heart is pumping and even tiny movements of your heart muscle that might be early signs of strain. The AI can do this much faster and often more accurately than a human.

We're following about 1500 patients who have severe aortic stenosis and are having their heart valve replaced. We're looking at the AI's measurements from their heart scans taken before the operation. Then, we will check on these patients two years later to see how they're doing. We want to see if the early changes spotted by the AI on the scans can predict who might have problems, like needing to go back to the hospital for heart issues, after their valve replacement. We'll also do another AI-powered heart scan two years later to see how the heart has changed. This study is important because knowing the best time for surgery could improve future care for many people with this condition.

Key takeaways

Aims to improve care for people with a heart valve problem called aortic stenosis.
Uses special AI software to analyse detailed heart scans (CMRs).
Looks for early signs of heart strain that human experts might miss.
Follows patients for two years after their heart valve operation.
Hopes to help doctors decide the best time for surgery in the future.

Who may be eligible?

To be considered for this study, you need to have a serious heart valve problem called severe aortic stenosis. Your medical team, at what's called a 'Heart Team' meeting, would be planning your treatment for this condition.

There are also some reasons why you might not be able to join. For example, if you can't have certain tests or attend follow-up appointments, or if you have metal implants in your body like some types of pacemakers or cochlear implants, as these can affect the special heart scans. Also, if you have severe kidney problems, you might not be able to take part.

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.

Do you have severe aortic stenosis?
Are you scheduled for a heart valve replacement, or is it being discussed by your doctors?
Are you willing and able to attend follow-up appointments?
Do you have any metal implants (like some pacemakers) that would prevent a heart scan?
Do you have very serious kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing involved is having a detailed heart scan (CMR scan) before your aortic valve replacement operation. This scan will be analysed using the special AI program. You will then have your planned heart valve replacement surgery as normal. Two years after your surgery, you will have another follow-up appointment, which will include another CMR scan. The study will look at the results of these scans and your health information over that two-year period. Your participation will involve about two years of follow-up after your operation.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information we gather could help doctors in the future make better decisions for people with aortic stenosis. The main potential risks are those associated with the CMR scans, which are generally very safe but cannot be performed if you have certain metal implants. Your privacy will be protected, and all your information will be kept confidential. You are free to withdraw from the study at any time without your medical care being affected.

Locations (7)

Medical University of Vienna
Verified postcode
Vienna, Austria
Université Catholique de Louvain
Verified postcode
Brussels, Belgium
University of Goettingen Medical Center
Verified postcode
Göttingen, Germany
Vilnius University
Verified postcode
Vilnius, Lithuania
Samsung Medical Center
Verified postcode
Seoul, South Korea
Seoul National University College
Verified postcode
Seoul, South Korea
Barts Heart Centre
Verified postcode
London, United Kingdom

Common questions

What is Aortic Stenosis?

It's a condition where one of your heart valves narrows, making your heart work harder to pump blood.

What is AI?

AI stands for Artificial Intelligence. It's a computer program that can perform tasks that usually require human intelligence, like analysing detailed medical images.

What is a CMR scan?

A Cardiac Magnetic Resonance (CMR) scan is a detailed scan that uses magnets and radio waves to create clear pictures of your heart, without using X-rays.

Will this study change my treatment?

No, your treatment decisions will be made by your doctors as normal. This study aims to gather information that could help future patients.

How long will I be involved in the study?

You'll be followed for about two years after your heart valve replacement operation.