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RecruitingNAINTERVENTIONAL

Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II

This study is looking at a new smartphone-connected device called the AliveCor 12-lead ECG. This device is designed to measure your heart's electrical activity, similar to a regular ECG you'd have in a hospital. The main goal is to find out if this new, portable device can accurately spot different types of heart attacks, specifically STEMI and NSTEMI, in people who come to the hospital with chest pain. Researchers want to ensure it works just as well as the larger, traditional ECG machines already in use. If successful, this technology could make it easier and quicker to check for heart problems, potentially helping doctors make faster decisions about treatment for patients experiencing symptoms like chest pain.

At a glance

Status
Recruiting
Phase
NA
Sponsor
AliveCor
Enrolment target
1,000
Start
12 Mar 2024
Estimated completion
01 Mar 2027

What is this study about?

Imagine a small device that connects to your smartphone and can check your heart's electrical signals, similar to how a hospital ECG works. That's what this study is all about. Researchers are testing a new gadget called the AliveCor 12-lead ECG. Doctors use ECGs to get an 'electrical picture' of your heart, which helps them detect serious conditions like a heart attack.

Currently, if you go to A&E with chest pain, doctors would use a standard ECG machine. This study wants to see if the new AliveCor device can provide the same accurate information about your heart as the hospital's bigger machines. They are particularly interested in whether it can reliably identify specific types of heart attacks called STEMI and NSTEMI, which are very important for doctors to diagnose quickly.

The idea is that if this smartphone-based device works well, it could offer a quick and easy way to check people for heart problems, potentially even before they arrive at the hospital or in busy emergency departments. This could help doctors make faster decisions and ensure patients get the right care as soon as possible.

Key takeaways

  • This study is testing a new smartphone-connected heart monitoring device.
  • It aims to see if the device can accurately detect heart attacks in people with chest pain.
  • The new device is being compared to standard hospital ECG machines.
  • If successful, it could offer a quicker way to check for heart problems.
  • Participation is only for adults experiencing chest pain in A&E.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You'll need to be able to understand and sign a consent form, which explains everything about the study, before you start.

The main requirement for taking part is experiencing chest pain when you arrive at the hospital's Emergency Department. The study is specifically looking at people with these kinds of symptoms.

However, you won't be able to join if you can't or won't sign the consent form. Also, if the lead doctor feels there are other reasons why taking part might be risky for you, or might affect the study's results, you wouldn't be able to participate.

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. Do you understand what the study involves and are happy to sign a consent form?
  3. Are you currently experiencing chest pain and attending A&E?
  4. Has a doctor told you that there are no reasons why you shouldn't take part?
Answer every question to see your result.

What does participation involve?

This study involves people who arrive at the Emergency Department or cardiac unit with chest pain. If you meet the criteria, you would be asked to have an ECG taken using the new AliveCor 12-lead device. This would happen alongside the standard ECG that you would normally receive as part of your care. The study is essentially comparing the results of the new device with the results from the hospital's usual ECG. There isn't any medication involved, and you won't need extra follow-up visits specifically for the study, as the comparison happens during your initial assessment. The total duration of your participation would only be for the time it takes to perform these ECGs.

Potential risks and benefits

Potential benefits of taking part could include helping to develop new technology that might improve how heart problems are diagnosed in the future. The risks involved are minimal, as the AliveCor device records your heart's electrical activity similarly to a standard ECG; it does not involve any injections or invasive procedures. You will also have a standard ECG done regardless of your participation in the study. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic
    Verified postcode
    Rochester, United States· Recruiting
  • Intermountain Health
    Verified postcode
    Murray, United States· Recruiting
  • Leeds General Infirmary
    Verified postcode
    Leeds, United Kingdom· Not yet recruiting
  • University of Edinburgh
    Verified postcode
    Edinburgh, United Kingdom· Not yet recruiting

Common questions

What is an ECG?

An ECG (electrocardiogram) is a simple, painless test that records the electrical activity of your heart. It helps doctors see how well your heart is working.

What is a heart attack?

A heart attack happens when the blood flow to a part of your heart is blocked, often by a blood clot. This can damage the heart muscle.

What is the AliveCor 12-lead ECG?

It's a new device that connects to a smartphone and can measure your heart's electrical signals, similar to a traditional ECG machine. This study is testing how well it works.

Will this device replace my doctor?

No, this device is designed to assist doctors by providing information about your heart. Your doctor will always interpret the results and make treatment decisions.

Do I have to take part if asked?

No, taking part is completely voluntary. Your decision will not affect the medical care you receive.

How to find out more

Kimberly Roohi, MS

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 "Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardia…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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