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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG Smartwatch for up to 1 year | Active Comparator | Cardiac monitoring with a smartwatch that support the recording of a single-lead electrocardiogram (ECG) over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM) |
|
| Holter monitoring for up to 1 year | Active Comparator | 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 |
|
| Control group | Other | Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG smartwatch | Device | Testing ECG smartwatch to detect AF or potential signs of AF |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
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| Insertable Cardiac Monitor (ICM) | Device | Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch) |
|
| External ECG Monitoring | Device | Regular cardiac monitor for diagnosis of AF |
|
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 American Heart Association's recommendations, including blood pressure, lipids, glucose, body mass index, nicotine exposure, diet, physical activity, and sleep health. Sub-study analysis will be perform considering data from smartwatch such as sleep, physical activity, and other health behavior. | 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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