Improving AF Detection in Cryptogenic Stroke (NCT05007847) | Clinical Trial Compass
CompletedNot Applicable
Improving AF Detection in Cryptogenic Stroke
United Kingdom27 participantsStarted 2022-02-04
Plain-language summary
No cause for stroke is found in up to 30% of cases despite extensive investigations. These are called cryptogenic strokes (CS). 1 in 4 stroke survivors will suffer another in 5 years and this is a leading cause of fear and anxiety. A common reason for CS is an undetected heart rhythm disorder called atrial fibrillation (AF). AF occurs intermittently, so it may not be detected during the mandated 24-96 hours of rhythm monitoring that is performed as part of the standard post-stroke investigation strategy.
A randomised controlled study in 2014 showed that whereas this standard monitoring strategy picks up AF in 2% of CS patients, longer-term, continuous monitoring for 12 months can pick up AF in 13% of patients. This suggests the standard strategy may miss AF in a proportion of CS patients and thus also the opportunity to mitigate against further strokes with anticoagulation therapy. Prolonged monitoring has traditionally required a minimally-invasive surgical procedure to implant a recording device under the skin at a specialist centre. A specifically trained team is also required to interpret the large number of recordings this strategy yields.
The Apple Watch (AW) is a wristwatch able to monitor a wearer's heart rate and rhythm regularity and facilitates real- time, single-lead ECG recordings. This over-the-counter, non-invasive device has demonstrated feasibility and has a Certification (CE) Mark for detecting AF. It may offer a potential non-invasive alternative long-term rhythm surveillance strategy to diagnose AF in these patients.
The investigators propose a study in which CS patients will be randomised in a 1:1 ratio to receive additional AW monitoring on top of standard care versus standard care alone. The investigators shall then explore the incidence of AF in the two groups at 1 year and how it impacts clinical outcomes too.
Who can participate
Age range
30 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Recent stroke or TIA event (\<90 days) that is supported by consistency between symptoms and findings on brain magnetic resonance imaging (MRI) or computed tomography (CT). Patients with TIA will be enrolled only if symptoms at presentation were speech problems, limb weakness, or hemianopsia. Diagnosis shall be made by a Consultant Stroke physician.
* Stroke classified as cryptogenic following extensive investigations to rule out a cause as per local protocol, but to include at least:
* Trans-thoracic echocardiogram
* A period of at least 24-hour rhythm monitoring with no evidence of AF.
* MRI or CT-angiography of the brain
* Sufficient mobility and dexterity to perform an ECG recording on the AW by touching the dial on the watch when worn with the contralateral hand for 30 seconds.
* Access to a smartphone with Apple-operating system (OS) within their household for syncing with their watch.
* Participants must be able and willing to provide written informed consent to participate in the study.
Exclusion Criteria:
* Documented history of AF or atrial flutter.
* Expected to undergo heart surgery in the 1 year following the stroke event.
* Any episode of myocardial infarction, coronary intervention or coronary artery bypass grafting \<1 month prior to the stroke event
* Any other indication for oral anti-coagulation.
* Patient has a cardiac implantable electronic device in-situ already or is expected to undergo implantation in the 1 year followin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.