RecruitingOBSERVATIONAL

Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions

This study is investigating a heart condition called atrial fibrillation (AF) in people who have experienced 'silent strokes' or 'silent brain damage'. AF is a known cause of more serious strokes, but its link to these silent events isn't fully understood. Researchers believe that if we monitor the heart rhythms of people who've had silent strokes for a long time, we might find AF just as often as we do in people who've had more obvious strokes. The main goal is to see how many people with silent strokes are diagnosed with AF after two years of continuous heart monitoring. This could help doctors decide if long-term heart monitoring is useful for these patients.

At a glance

Status

Recruiting

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

150

Start

08 Sep 2020

Estimated completion

31 Dec 2029

Silent Stroke Silent Cerebral Infarct Fibrillation

What is this study about?

This study is about understanding a heart condition called atrial fibrillation (AF), which is a common type of irregular heartbeat. While AF is known to cause serious strokes, its role in what are called 'silent strokes' or 'silent brain damage' isn't as well understood. Silent strokes are changes in the brain that show up on scans but don't cause noticeable symptoms, so people often don't even know they've had one.

The researchers want to find out if AF is just as common in people who've had these silent strokes as it is in people who've had strokes with clear symptoms. They think that by continuously monitoring a person's heart rhythm for a long time, they will discover AF in many people who have had silent strokes. This study aims to track how many people with silent strokes are diagnosed with AF over two years.

The findings from this study could be very important. If the study shows that long-term heart monitoring helps find AF in people with silent strokes, it might lead to new ways of checking and treating these patients. Catching AF early could help prevent more serious health problems in the future. The study hopes to provide clear evidence to support the idea that long-term heart monitoring is beneficial for people with silent brain damage.

Key takeaways

This study investigates if a hidden heart problem (AF) is common in people with 'silent strokes'.
It uses a small, implanted heart monitor to continuously record your heart rhythm.
Finding AF early could help prevent future strokes.
The study monitors participants for about two years.
You won't be eligible if you've already had AF or stroke symptoms.
If a heart problem is found, your doctor will be informed to decide on treatment.

Who may be eligible?

To be considered for this study, you generally need to be 65 years old or older. If you're between 50 and 64, you might still be able to join if you have certain specific results from blood tests or heart and brain scans, such as a particular protein level in your blood, a specific heart chamber size, or damage in different parts of your brain.

You must have had silent brain damage, which are changes seen on a brain scan that didn't cause any symptoms you noticed. These changes need to fit specific patterns that doctors look for on MRI scans. You also need to be able to understand the study and agree to take part by signing a consent form.

You cannot join the study if you have ever been diagnosed with atrial fibrillation or a similar heart rhythm problem called atrial flutter. You also can't participate if you've already had symptoms of a stroke (even if you've had minor, unnoticed neurological issues), or if you have certain types of heart devices already implanted.

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.

Are you 65 or older, or between 50-64 with specific test results?
Have you had a 'silent stroke' or brain damage visible on a scan, but with no symptoms?
Have you never been diagnosed with atrial fibrillation or atrial flutter?
Do you not currently have an implanted heart device?
Are you willing and able to give your informed consent?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a small heart monitor (called a Reveal LINQ) implanted just under the skin. This is a minor procedure. This device will continuously record your heart's electrical activity. The information from your heart monitor will be sent wirelessly to your doctor through a 'Medtronic MyCareLink Patient Monitor' at home. The study staff will keep an eye on this data regularly.

If the monitor picks up any important heart rhythm problems, the study team will let your treating doctor and you know within two weeks. These problems could include a first episode of atrial fibrillation lasting at least 30 seconds, very fast or very slow heartbeats, or long pauses in your heartbeat. It will then be up to your doctor to decide on the best course of action. The study does not specify a total duration, but the main goal is to track you for 24 months to see how many people are diagnosed with AF.

Potential risks and benefits

Participating in this study could offer a potential benefit by identifying an underlying heart rhythm problem like atrial fibrillation that you weren't aware of. Discovering AF could lead to treatments that reduce your risk of more serious strokes in the future. However, there are potential risks, including those associated with the minor procedure to implant the heart monitor, such as infection or discomfort at the implant site. There's also the chance that finding an irregular heartbeat might lead to further tests or treatments that you wouldn't have had otherwise. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Universitätsspital Graz
Verified postcode
Graz, Austria· Recruiting
Charite Berlin
Verified postcode
Berlin, Germany· Not yet recruiting
Centre hospitalier universitaire vaudois (CHUV)
Verified postcode
Lausanne, Switzerland· Recruiting
Kantonsspital Aarau
Verified postcode
Aarau, Switzerland· Active not recruiting
University Hospital Basel
Verified postcode
Basel, Switzerland· Recruiting
Inselspital Bern
Verified postcode
Bern, Switzerland· Recruiting
Kantonsspital St.Gallen
Verified postcode
Sankt Gallen, Switzerland· Recruiting
Universitätsspital Zurich
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is 'silent stroke'?

A silent stroke is damage to the brain that shows up on a scan but doesn't cause any symptoms you would notice, so you might not even know you've had one.

What is atrial fibrillation (AF)?

Atrial fibrillation is a common type of irregular and often rapid heartbeat that can increase the risk of stroke.

Will I feel the heart monitor?

The heart monitor is a small device implanted just under your skin. You might feel it initially, but most people get used to it quickly.

What happens if they find a problem?

If the monitor finds an important heart rhythm problem, the study team will inform your doctor and you within two weeks, and your doctor will discuss next steps.

How long will I be monitored?

The main part of the study aims to monitor your heart continuously for 24 months (two years).

How to find out more

Laurent Roten, PD Dr. med.

laurent.roten@insel.ch +41 31 632 52 63 Official trial record

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