A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy
This research study is looking for people in the UK who have heart muscle damage due to problems with blood flow (ischaemic cardiomyopathy) and are set to receive a special heart device called a CRT. The main goal is to find out if using detailed MRI scans to help guide where the CRT device is placed works better than the standard way of doing it. We want to see if this new approach can lead to a bigger improvement in how well the heart pumps blood. Participants will have their heart health checked at the start, during the device placement, and several times afterwards over a six-month period. We're mainly looking to see if more people have a significant improvement in their heart's pumping ability after six months with the MRI-guided method.
At a glance
What is this study about?
This study is about a type of heart treatment called CRT, which stands for Cardiac Resynchronisation Therapy. It's a special device, similar to a pacemaker, that helps the different chambers of your heart beat in a more organised way. This can be very helpful for people whose heart isn't pumping blood effectively, particularly if the problem is due to damage from poor blood flow, often after a heart attack. If you need a CRT device, this study is comparing two ways of putting it in.
One way is the standard method that doctors have been using for a while. The other is a newer approach where doctors use very detailed MRI scans of your heart to guide exactly where the wires of the CRT device should be placed. The idea behind this new method is that by having a more precise map of your heart, doctors might be able to put the device in the best possible spot to help your heart pump more efficiently. We believe that this could lead to better results for patients.
We want to see if using these MRI scans leads to more people showing a real improvement in how well their heart works after the CRT device is put in, compared to the standard method. By finding this out, we hope to improve the treatment for people with this type of heart condition in the future.
Key takeaways
- The study compares two ways of fitting a special heart device (CRT).
- It aims to see if MRI scans can guide device placement better than the standard method.
- The study is for people with heart muscle damage from poor blood flow who need a CRT device.
- Participation lasts six months and involves check-ups and heart scans.
- Your medical care will not be affected if you choose not to participate or withdraw.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been told by your doctor that you need a CRT device, following UK medical guidelines. Your heart condition should be stable after at least three months of your usual medications. This study is specifically for people where heart muscle problems are caused by a lack of blood flow, often called ischaemic cardiomyopathy. Even if you have atrial fibrillation, you might still be able to join.
However, some things would mean you can't take part. This includes if you can't have a pacemaker or a similar device fitted, or if you need a specific type of pacing called 'endocardial pacing'. You also can't participate if you can't have an MRI scan with a special dye (gadolinium contrast) – for example, if you have severe kidney problems (eGFR below 30) or if you are very claustrophobic and can't lie still in the MRI scanner.
Additionally, if you already have a pacemaker or similar device, or if one was removed within the last six months, you won't be able to join. If you're currently in another medical study that involves receiving a new treatment, or if you are pregnant or planning to become pregnant in the next seven months, this study wouldn't be suitable for you.
- Are you 18 years old or older?
- Has your doctor told you that you need a CRT device?
- Is your heart problem due to damage from a lack of blood flow?
- Are you able to have an MRI scan with dye and lie still in the scanner?
- Do you not have an existing pacemaker or similar device, or had one removed within the last six months?
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, you'll be part of the study for about six months in total. You'll have an initial check-up to make sure you're suitable. Then, during your CRT device fitting, you might have the standard procedure or one guided by MRI scans, depending on which group you're randomly assigned to. You'll have check-ups just before you leave the hospital, and then again after about six weeks and six months. These check-ups will involve having an ultrasound scan of your heart (called an echocardiogram) to see how well it's working. All your usual medications for your heart condition will continue as normal.
Potential risks and benefits
Locations (1)
- Guys and St Thomas NHS Foundation TrustLondon, United Kingdom· Recruiting
Common questions
What is a CRT device?
A CRT (Cardiac Resynchronisation Therapy) device is a small device, like a special pacemaker, that helps the different parts of your heart beat together more efficiently to improve its pumping action.
What does 'ischaemic cardiomyopathy' mean?
This means your heart muscle has been damaged because it wasn't getting enough blood flow, often due to conditions like a heart attack, which then affects its ability to pump properly.
Will I definitely get the new MRI-guided treatment?
No, participants will be randomly assigned to either receive the MRI-guided treatment or the standard treatment. This is to fairly compare the two methods.
What is an MRI scan for this study?
It's a detailed scan of your heart using magnetic fields and radio waves, sometimes with a special dye, to create clear pictures that help doctors see how your heart is working and its structure.
How long will I be involved in the study?
If you join, you will be part of the study for a total of six months, with several check-ups during that time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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