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The PICM Risk Prediction Study - Application of AI to Pacing

This research is looking at why some people with pacemakers develop a specific heart problem called pacemaker-induced cardiomyopathy (PICM). PICM can lead to more hospital stays for heart failure and can be serious. At the moment, it's hard to tell who is at risk of PICM, which means we can't offer them different types of pacemakers that might help prevent it. Scientists are using special computer programs (artificial intelligence, or AI) to study the health records and heart scans of many patients who have had pacemakers. They want to find patterns that show who develops PICM and who doesn't. The goal is to create a new way to predict a person's risk, so doctors can choose the best pacing treatment to keep their hearts healthy and prevent this problem from happening.

At a glance

Status
Not yet recruiting
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrolment target
10,000
Start
30 Jul 2024
Estimated completion
30 Oct 2026

What is this study about?

Heart failure is a condition where your heart can't pump enough blood around your body. Some people need a device called a pacemaker to help their heart beat regularly. However, for a small number of people, the pacemaker itself can sometimes lead to a type of heart failure called pacemaker-induced cardiomyopathy, or PICM. When this happens, the heart muscle can become weakened over time.

Currently, doctors don't have a good way to predict which patients with a pacemaker might develop PICM. This means they can't offer preventative treatments, such as different types of pacemaker settings or additional leads to help the heart pump better, to those who might benefit most. This study aims to change that.

Researchers are using advanced computer technology, sometimes called 'artificial intelligence' or 'AI', to look back at the health information of many patients who have received pacemakers. They will examine details like heart tracings (ECGs), scans of the heart (such as MRI, CT, or echocardiograms), and information about their overall health. By comparing people who developed PICM with those who didn't, the AI can learn to spot patterns and warning signs. The hope is to create a 'smart' prediction tool that can help doctors identify patients at risk early on. This could lead to more personalised pacemaker treatments, helping to prevent PICM and improve heart health for many.

Key takeaways

  • This study uses artificial intelligence to understand pacemaker-related heart weakness (PICM).
  • It reviews existing medical records from patients with pacemakers.
  • The goal is to predict who might develop PICM to offer better preventative care.
  • There are no direct actions needed from patients, as it uses anonymised past data.
  • Findings could help avoid heart problems in future pacemaker patients.

Who may be eligible?

This study is looking at information from medical records of people who have already had a pacemaker fitted. You don't need to do anything or attend any appointments for this study.

Researchers will be looking at records from patients aged 18 or older who received any type of pacemaker (like a VVI, DDD, ICD, or leadless pacemaker) at certain hospitals (GSTT, RBH, KCH, ICH) within the last 10 years, starting from January 1, 2014.

They will not be including anyone under 18 years old. Also, if you have certain other heart conditions, like a heart defect you were born with, or if you've had major heart surgery (like a heart valve replacement or bypass surgery), your records won't be used. Finally, if you didn't have an important heart scan called an echocardiogram after your pacemaker was implanted, your records won't be included either.

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.

  1. Did you receive a pacemaker at GSTT/RBH/KCH/ICH?
  2. Was your pacemaker fitted from January 1, 2014, onwards?
  3. Are you 18 years old or older?
  4. Did you have an echocardiogram (heart scan) after your pacemaker was fitted?
  5. Have you NOT had certain other heart conditions or major heart surgery?
Answer every question to see your result.

What does participation involve?

This study looks back at existing medical records and information. If your records are selected to be part of the study, you will not need to do anything or attend any extra appointments. You will not have to take any medicine, and there will be no follow-up assessments for you. Your participation involves allowing researchers to review your past health information from when you received your pacemaker and afterwards. The total duration of your 'involvement' would simply be the time it takes for researchers to review your anonymised data.

Potential risks and benefits

Because this study only uses information from existing health records, there are no direct risks or benefits to you as an individual patient. Your personal identity will be protected, and researchers will only look at your anonymised data. The potential benefit of this research is for future patients: by learning more about pacemaker-induced heart problems, doctors hope to develop better ways to predict and prevent these conditions, leading to improved heart health for many. As this is not a direct interaction study, there is no 'withdrawal' in the traditional sense, as your information will be anonymised and part of a larger dataset.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Guys' and St Thomas' Hospital NHS Trust
    Verified postcode
    London, United Kingdom
  • Kings' College London Healthcare Trust
    Verified postcode
    London, United Kingdom
  • Imperial College London Healthcare Trust
    Verified postcode
    London, United Kingdom

Common questions

What is pacemaker-induced cardiomyopathy (PICM)?

It's a type of heart weakness that can sometimes happen in people who have a pacemaker fitted.

Do I need to do anything if my information is used?

No, you don't need to do anything. This study only looks at past medical records.

Will my name or personal details be shared?

No, your personal identity will be kept private. Researchers will only use anonymised information.

How will this study help patients?

It aims to help doctors better predict who might get PICM, so they can offer more tailored treatments to prevent it in the future.

Is this a new type of treatment trial?

No, it's a research study using existing patient data to understand a condition better, not a trial of a new drug or procedure.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "The PICM Risk Prediction Study - Application of AI to Pacing…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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