Clinical trial NCT05007847: Improving AF Detection in Cryptogenic Stroke
Official title: A Non-invasive, Prolonged Surveillance Strategy Using Apple Watch for Atrial Fibrillation Detection in Cryptogenic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptogenic Stroke
Atrial Fibrillation
Keywords: cryptogenic stroke
atrial fibrillation
wearable
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose a prospective, randomised controlled study to determine our hypothesis. This single-centre, investigator-initiated trial will be performed at Barts Health NHS Trust which provides tertiary cardiac electrophysiology services to 4 stroke units part of the London Stroke Care Network (SCN).

Participants will be randomised on day 0 to either the active or control study arm. Participants randomised to the active arm will be provided with an AW Series 4 on Day 0 for the duration of the study. All participants will be followed up for 12 months after enrolment.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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 following the stroke event (excluding implantable loop recorder for the investigation of the CS).
* Previous left atrial (LA) ablation or LA surgery
* Life expectancy less than 1 year

Primary outcomes:
measure: Atrial fibrillation detection rate
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of non-elective, hospital admissions.
timeFrame: 12 months
measure: Incidence of recurrent stroke or TIA.
timeFrame: 12 months
Other outcomes:
measure: Exploratory study of correlation between participant activity and AF
timeFrame: 12 months
Locations:
city: City Of London
country: United Kingdom
facility: St Bartholomew's Hospital
state: London
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: UK
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: Barts & The London NHS Trust
name: Richard Schilling
role: PRINCIPAL_INVESTIGATOR
References: