Cryptogenic Stroke, Paroxysmal Atrial Fibrillation
Conditions
Keywords
Wearable Electronic Devices
Brief summary
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
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.
Interventions
DEVICEECG smartwatch
Testing ECG smartwatch to detect AF or potential signs of AF
DEVICEInsertable Cardiac Monitor (ICM)
Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
DEVICEExternal ECG Monitoring
Regular cardiac monitor for diagnosis of AF
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased probability of detecting AF | Assessed throughout 1 year trial period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Atrial Fibrillation using a ECG smartwatch | Assessed throughout 1 year trial period | Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor |
| Usability and adherence to ECG Smartwatch | Assessed throughout 1 year trial period | 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. |
| Control of vascular risk factors (VRF) | Assessed at the end of the 1 and 2 year trial period | 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. |
| Vascular events incidence | Assessed at the end of the 1 and 2 year trial period | 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 |
| Predictors of vascular recurrence | Assessed at the end of the 1 and 2 year trial period | 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. |
Countries
Spain
Outcome results
None listed