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Enrolling by invitationOBSERVATIONAL

Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study

This research is looking at whether Artificial Intelligence (AI) can help doctors diagnose a serious lung condition called Pulmonary Hypertension (PH) using a common heart test called an ECG. Early diagnosis of PH is very important as it can lead to more effective treatments sooner, which can improve a patient's health and how well they live. The study will use existing ECGs from patients who have already had a special heart test (Right Heart Catheterisation) to see if AI can spot signs of PH. Researchers want to know if AI can accurately detect PH, identify its different types, and even help predict how the condition might progress. No extra tests are needed for people taking part.

At a glance

Status
Enrolling by invitation
Sponsor
Royal United Hospitals Bath NHS Foundation Trust
Enrolment target
600
Start
01 Oct 2023
Estimated completion
01 Aug 2027

What is this study about?

This study aims to discover if a new technology called Artificial Intelligence (AI) can help doctors diagnose a serious lung condition called Pulmonary Hypertension (PH) earlier and more accurately. PH happens when the blood pressure in the arteries going from the heart to the lungs becomes too high. Diagnosing PH can sometimes be challenging, and getting an early and correct diagnosis is really important because it means patients can start effective treatments sooner. These treatments can significantly improve how they feel and their overall health.

Researchers are using AI with a common, quick, and painless heart test called an electrocardiogram (ECG). An ECG involves placing sticky pads on your chest, arms, and legs to record your heart's electrical activity. Currently, to get a definite diagnosis of PH, patients need a more complex test called a Right Heart Catheterisation (RHC). This study will look at ECGs from patients who have already had an RHC to see if the AI can pick up signs of PH from their ECGs, even before the RHC was done.

The main questions this study hopes to answer are: Can AI accurately find PH from an ECG? Can it tell the difference between the different types of PH? And can it even help predict key outcomes for patients with PH? The study will involve looking at old and new ECGs, along with some anonymous health information, but no one will need to have any extra tests or appointments specifically for this research.

Key takeaways

  • The study uses AI with existing ECGs to improve PH diagnosis.
  • Early diagnosis of PH can lead to better treatments.
  • No extra tests or special appointments are needed to participate.
  • Your medical care will not be affected by this research.
  • All your personal information will be kept private and anonymous.

Who may be eligible?

To be included in this study, you must be 18 years old or older. You would have either been referred to the Bath Pulmonary Hypertension service from July 2023 onwards and had a special heart test called a Right Heart Catheterisation (RHC) and an ECG as part of your routine care.

Alternatively, if you were referred to the same service between 2007 and June 2023, you might be included if you had an RHC and an ECG within a year of that RHC. Even if someone has sadly passed away, their anonymised records might still be used if they meet these criteria.

You would not be eligible if you are under 18, have not had an RHC to check for PH, or if you didn't have an ECG within 12 months of your RHC. If you are alive, you also need to agree to be part of the study.

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. Are you 18 years old or older?
  2. Have you had a special heart test called a Right Heart Catheterisation (RHC)?
  3. Did you have an ECG done around the same time (within 12 months) of your RHC?
  4. Do you or did you receive care from the Bath Pulmonary Hypertension service?
Answer every question to see your result.

What does participation involve?

If you are part of this study, you won't need to do anything extra. This research uses information from your existing medical records, specifically your ECGs that were done as part of your normal heart health checks, and details from your routine clinical care. There are no study visits, no extra tests, no medications to take, and no changes to your usual medical care. Researchers will follow up on your health information for up to three years, collecting anonymous data on how you're doing, but this doesn't require any active participation from you.

Potential risks and benefits

There are no direct risks to you from taking part in this study, as it only involves reviewing your routine, anonymised medical information. You will not have any extra tests or procedures. The potential benefit is that the results could lead to earlier and more accurate diagnosis of Pulmonary Hypertension in the future, which could improve treatments and lives for many patients. You have the right to withdraw your consent at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal United Hospital Bath NHS Trust
    Verified postcode
    Bath, United Kingdom

Common questions

What is an ECG?

An ECG is a simple, painless test that records the electrical activity of your heart. It helps doctors check your heart's rhythm and overall health.

What is Pulmonary Hypertension (PH)?

Pulmonary Hypertension is a serious condition where the blood pressure in the arteries leading to your lungs becomes too high, making your heart work much harder.

Will this study affect my current medical care?

No, this study will not affect your current medical care in any way. It only uses information from tests you've already had or will have as part of your usual treatment.

Is my personal information kept private?

Yes, all your personal information is kept strictly private. The researchers will only use anonymised data, meaning your name and other identifying details will be removed.

Do I have to do anything if I'm included?

No, you don't need to do anything. This study uses existing medical records and does not require any active participation, extra tests, or visits from you.

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 "Applying Artificial Intelligence to the 12 Lead ECG for the …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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