RecruitingNAINTERVENTIONAL

Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.

If you've had a stroke where doctors couldn't find a clear cause, this study might be for you. An irregular heartbeat called atrial fibrillation (AF) can cause strokes. Currently, we can implant small heart monitors to find AF after these unexplained strokes, but they involve a small operation and can be costly. This study explores whether a special heart MRI scan can help predict who is more likely to develop AF. If successful, this could mean fewer people need the implantable monitor, as the MRI could help doctors choose who would benefit most. Taking part involves having a heart MRI scan within three months of your stroke.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

100

Start

31 Jan 2024

Estimated completion

01 Jan 2030

Stroke Implantation of an Implantable Cardiac Monitor

What is this study about?

When someone has a stroke, doctors always try to find out what caused it. Sometimes, even after many tests, the cause remains a mystery. This is called an ischemic stroke of undetermined origin. One common cause of stroke is an irregular heartbeat called atrial fibrillation (AF). In AF, the top chambers of the heart beat very quickly and irregularly, which can lead to blood clots forming and travelling to the brain, causing a stroke.

Currently, if you've had this type of unexplained stroke, doctors might suggest implanting a small heart monitor under your skin. This monitor continuously checks your heart rhythm for several years to catch any episodes of AF that might occur. While these monitors are good at finding AF, they require a minor operation and can be quite expensive. This study aims to find a better way to predict who truly needs one of these monitors.

Researchers think that using a special type of heart scan, called a cardiac MRI, might help. This scan can show if there's any 'scar tissue' in the left atrium, which is the heart chamber where AF often starts. The idea is that if the MRI can show who has more of this scar tissue, it might tell us who is more likely to develop AF and therefore who would benefit most from having an implantable heart monitor. This could mean that fewer people would need to have the monitor implanted unnecessarily.

Key takeaways

This study investigates if a heart MRI can help predict who will develop an irregular heartbeat (AF) after an unexplained stroke.
The goal is to improve how doctors decide who needs an implantable heart monitor.
If you qualify, you'll have one heart MRI scan with a special dye.
Participation is voluntary and won't affect your regular medical care.
This research hopes to refine stroke prevention strategies.

Who may be eligible?

To join this study, you must be an adult who has had a stroke where the cause wasn't clear, and this stroke happened within the last 30 days. Your doctors should also be planning to give you an implantable heart monitor within three months of your stroke to specifically look for an irregular heartbeat called atrial fibrillation (AF).

You shouldn't have had AF diagnosed before your stroke, and you shouldn't be taking blood thinners for a long time. You also need to be expected to live for more than a year. Importantly, you can't be pregnant, breastfeeding, or have certain conditions that would make an MRI scan unsafe, like severe kidney problems, claustrophobia, or metal in your body that isn't safe for MRIs.

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 an adult (18 years or older)?
Have you recently had a stroke where the cause wasn't clear, within the last 30 days?
Are your doctors planning to implant a heart monitor soon to look for an irregular heartbeat?
Have you never been diagnosed with atrial fibrillation before your stroke?
Do you have no known contraindications for an MRI scan (like severe kidney problems, metal implants not safe for MRI, or severe claustrophobia)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to have your regular check-ups with your heart and brain doctors. In addition to your usual care, you will have one special heart MRI scan. This scan will happen within three months of your stroke and will involve having a special dye injected into your arm to help the pictures show up clearer. The total duration of your participation in the study itself is just for this specific MRI scan and the follow-up of your results.

Potential risks and benefits

A potential benefit of joining this study is that your heart MRI results could help your doctors better understand your risk of developing an irregular heartbeat (atrial fibrillation) and decide if an implantable heart monitor is the best option for you. The main risk involved is having an MRI scan, which involves lying still in an enclosed space and receiving a contrast dye injection. While generally safe, some people might experience claustrophobia or have a rare allergic reaction to the dye. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Chu Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is an 'unexplained stroke'?

It's a stroke where doctors can't find a clear reason why it happened, even after doing many tests.

What is atrial fibrillation (AF)?

It's a common type of irregular and fast heartbeat that can increase the risk of stroke.

What is a cardiac MRI?

It's a special type of scan that uses strong magnets and radio waves to create detailed pictures of your heart, sometimes with a special dye to make things clearer.

What's an implantable heart monitor?

It's a small device placed under the skin that constantly records your heart's electrical activity to detect irregular rhythms like AF.

Do I have to pay to be in this study?

No, you will not have to pay to participate in this study. The study-related MRI scan will be covered.

How to find out more

Charles GUENANCIA

charles.guenancia@chu-dijon.fr 0380295623 Official trial record

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