Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

Study Overview
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Brief Summary
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Stroke recurrence largely depends on the detection of the cause and the control of vascular risk factors, with occult atrial fibrillation (AF) being one of the most important. Prolonged ambulatory cardiac monitoring is recommended for detecting occult AF. Currently, there are non-invasive monitoring devices such as the textile Holter that have proven to be useful for monitoring for up to 30 days but not longer. Another alternative is smartwatches, although they must be validated for use in the elderly population who have had a stroke.

Detailed Description
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The primary objective is to demonstrate that the protocol of ambulatory cardiac monitoring with wearable devices for 12 months allows detection of a higher percentage of occult AF than monitoring for 30 days. The secondary objectives will be to demonstrate the internal validity of smartwatches against insertable cardiac recorders for the detection of AF. To evaluate the usability and adherence to the use of smartwatches in patients with stroke. Detect predictors that can help detect long-term occult AF. Determine the profile of vascular events in each group. Detect predictors of vascular recurrence defined as stroke recurrence, incidence of cerebral hemorrhage, heart failure, myocardial infarction or vascular death.

Official Title
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Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke

Conditions
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Paroxysmal Atrial Fibrillation, Cryptogenic Stroke

Intervention / Treatment
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* Device: ECG smartwatch
* Device: Insertable Cardiac Monitor (ICM)
* Device: External ECG Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater to or equal to 55 years Patients with diagnosis of cryptogenic stroke after a basic study that included neuroimaging, extra/intracranial vascular evaluation, 24-hour monitoring, and echocardiogram Patients with acute cortical infarction with the presence of intracranial occlusion (preferably) Modified Rankin Scale (mRS) lower to 4 Exclusion Criteria: Diagnosis of lacunar infarction or transient ischemic attack (TIA) Diagnosis of stroke of known source: atherothrombotic due to moderate or severe symptomatic extra/intracranial stenosis, major cardioembolic cause (atrial fibrillation, anterior or apical ventricular akinesis, causal PFO, post-AMI, flutter or mitral stenosis), unusual cause (thrombophilia, arterial dissection symptomatic, toxic) Use of pacemakers Circumstances that may preclude the clinical follow-up or reduce the possibilities of obtaining data to achieve the objectives of the study and/or limit contact with the investigator (for example, transfer to a social health center) Unwillingness to the use of cardiac monitoring wearable devices Not understanding study procedures

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECG Smartwatch for up to 1 year<br>Cardiac monitoring with an ECG Smartwatch over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM) | Device: ECG smartwatch<br>* Testing ECG smartwatch<br>Device: Insertable Cardiac Monitor (ICM)<br>* Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)<br>|
| Active Comparator: Holter monitoring for up to 1 year<br>Cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year | Device: External ECG Monitoring<br>* Regular cardiac monitor for diagnosis of atrial fibrillation<br>|
| Other: Control group<br>Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke | Device: External ECG Monitoring<br>* Regular cardiac monitor for diagnosis of atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased probability of detecting AF | To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result. | Assessed throughout 1 year trial period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Atrial Fibrillation using a ECG smartwatch | Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor | Assessed throughout 1 year trial period | 
| Usability and adherence to ECG Smartwatch | To evaluate the usability to the use of the ECG Smartwatch through the System usability scale (SUS) and self-reported of likes or dislikes encountered with wearable. | Assessed throughout 1 year trial period | 
| Control of vascular risk factors (VRF) | To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the AHA Life Simple 7 factors. Ideal metrics were defined as follows: (1) Smoking status: never or former smoker; (2) BMI: <25 kg/m2; (3) Physical activity: ≥150 min/wk of moderate-intensity physical activity; (4) Healthy diet: 4 or 5 fruits/vegetables per day; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL. | Assessed at the end of the 1 and 2 year trial period | 
| Vascular events incidence | To describe the vascular events defined as recurrence of stroke, the incidence of cerebral hemorrhage, heart failure, myocardial infarction, or vascular death in each study group | Assessed at the end of the 1 and 2 year trial period | 
| Predictors of vascular recurrence | To identify predictors of vascular recurrence (recurrent stroke, cerebral hemorrhage, heart failure, myocardial infarction, or vascular death) in each study group. Predictors of vascular recurrence included sociodemographic data such as age, sex and education level; BMI (kg/m2); history of diabetes mellitus; LDL-cholesterol and medications, such as the use of anti-hypertensive medications, lipid-lowering medications, and antiplatelet therapy. Also clinical symptoms, neuroimagen and ECG parameters will be included in the analysis. | Assessed at the end of the 1 and 2 year trial period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable Electronic Devices