RecruitingNAINTERVENTIONAL

Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

This study aims to see if smartwatches can accurately detect a heart rhythm problem called Atrial Fibrillation (AFib) in people who have recently had a 'cryptogenic' stroke (where the cause isn't clear) or a 'mini-stroke' (TIA). AFib significantly increases the risk of another stroke, and finding it early means doctors can start treatment to prevent recurrences. Currently, doctors use implanted devices to monitor heart rhythm. This research wants to find out if smartwatches could be a simpler, less invasive, and more affordable way to do the same job. Participants will wear a smartwatch in addition to their standard monitoring device, and the study will compare how well both methods detect AFib over six months.

At a glance

Status

Recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

400

Start

15 Oct 2024

Estimated completion

01 Jul 2026

Ischemic Stroke, Cryptogenic Transient Ischemic Attack Atrial Fibrillation

What is this study about?

This research is looking into an important problem: preventing further strokes in people who have already had one. Specifically, it focuses on a type of stroke called a 'cryptogenic stroke,' which means doctors haven't been able to find a clear reason for it. After such a stroke, it's very important to check for a heart condition called Atrial Fibrillation (AFib). AFib is an irregular heartbeat that can cause blood clots to form, leading to another stroke. If AFib is found, often a treatment called 'anticoagulation' (blood thinners) can greatly lower the risk of future strokes.

Currently, finding AFib after a stroke often involves long-term monitoring with special devices, sometimes even ones implanted under the skin. While these work, they can be costly, involve a procedure, and sometimes people drop out of the monitoring process. Recently, smartwatches have become much more advanced and can now check heart rhythms. This study wants to see if these everyday devices could be just as good at finding AFib as the more traditional, invasive methods.

By comparing smartwatches to the current standard of care (implanted heart recorders), researchers hope to show that smartwatches could be a simple, affordable, and widely available tool to help doctors find AFib sooner. This could lead to more people getting the right treatment faster, ultimately helping to prevent many more strokes and improve people's health after a first stroke or 'mini-stroke' (TIA).

Key takeaways

This study compares smartwatches to implanted devices for detecting irregular heartbeats (AFib).
It's for people who've had a 'cryptogenic' stroke or TIA where the cause wasn't clear.
Finding AFib is key to preventing future strokes through medication.
Smartwatches could be a simpler, more affordable way to monitor heart rhythm.
Participation involves wearing a smartwatch for six months, alongside your existing monitor.
Medical specialists will review your smartwatch data for signs of AFib.

Who may be eligible?

You might be able to join this study if you've had a 'cryptogenic' stroke or a certain type of 'mini-stroke' (TIA) within the last six months, and doctors couldn't find a clear cause for it after thorough checks. You'll also need to have an implanted heart monitoring device already because that's what the smartwatch will be compared against.

You also need to be at least 40 years old and have certain risk factors linked to stroke or AFib, which your doctor would check. It's also important that you don't have any medical reasons preventing you from taking blood-thinning medication, should AFib be found.

You wouldn't be able to join if you don't have a newer smartphone (Apple or Android) that can connect to a smartwatch, or if you can't do the single-lead ECG recordings on the smartwatch yourself. If you have a pacemaker or an implanted defibrillator, or if you are pregnant or breastfeeding, you also can't 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.

Have you had a 'cryptogenic' stroke or TIA (mini-stroke) in the last 6 months?
Do you already have an implanted heart monitoring device?
Are you 40 years old or older?
Do you own a smartphone (Apple or Android) that can use a smartwatch?
Are you able to perform a single-lead ECG reading on a smartwatch by yourself?
Are you able to take blood-thinning medication if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for a total of six months. You'll have an implanted heart monitoring device already, as this is part of the standard care for your condition. In addition to this, you will be given a smartwatch to wear. You'll use this smartwatch to regularly take readings of your heart's electrical activity (like a mini ECG).

Two specialist heart doctors will continuously check the heart data from your smartwatch. If they see signs of AFib, you'll have an appointment with a doctor to discuss starting blood-thinning medication. The study involves four check-ins over the six months: an initial visit, two phone calls at one and three months, and a final visit at the end of the six months.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping doctors understand better ways to detect AFib, which could lead to earlier treatment and potentially prevent future strokes for yourself and others. While the smartwatch monitoring is generally low-risk, participants who may experience emotional distress due to continuous heart monitoring or those who may detect arrhythmias that don't need treatment. The implanted heart monitor is already part of your standard care. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Klinikum rechts der Isar, Technische Universität München
Verified postcode
Munich, Germany· Recruiting

Common questions

What exactly is an 'AFib'?

AFib, or Atrial Fibrillation, is a common condition where the heart's upper chambers beat irregularly and often too fast. This can cause poor blood flow and raises the risk of blood clots, which can lead to a stroke.

What is a 'cryptogenic stroke'?

A cryptogenic stroke is a stroke where doctors have done a thorough investigation but haven't been able to find a clear, definite cause for it.

Why is it important to find AFib after a stroke?

Finding AFib after a stroke is crucial because it's a major cause of stroke. If found, starting special blood-thinning medication can significantly reduce the chance of having another stroke.

Will the smartwatch replace my current heart monitor?

No, if you join this study, you will have both the smartwatch and your existing implanted heart monitor. The study is comparing how well the smartwatch works against the implanted device.

What happens if the smartwatch detects AFib?

If your smartwatch data shows signs of AFib, your doctors will arrange an appointment for you to discuss starting medication that helps prevent blood clots, if appropriate for your situation.

How to find out more

Silke Wunderlich, Dr.med

silke.wunderlich@tum.de 0049(0)8941404606 Official trial record

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