Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke
Recruiting · NCT05565781 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
ECG smartwatchExternal ECG MonitoringInsertable Cardiac Monitor (ICM)
What this trial is about
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.
Who can take part
Age range
55 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Hospital Universitari Vall d'Hebron - Barcelona, Catalonia, Spain