Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECG smartwatch, Insertable Cardiac Monitor (ICM), External ECG Monitoring.
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation, Cryptogenic Stroke. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Overview
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
- Device ECG smartwatch
Testing ECG smartwatch to detect AF or potential signs of AF - Device Insertable Cardiac Monitor (ICM)
Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch) - Device External ECG Monitoring
Regular cardiac monitor for diagnosis of AF
Primary outcome measures
- Increased probability of detecting AF [Time frame: Assessed throughout 1 year trial period]
Secondary outcome measures (5)
- Identification of Atrial Fibrillation using a ECG smartwatch [Time frame: Assessed throughout 1 year trial period]
- Usability and adherence to ECG Smartwatch [Time frame: Assessed throughout 1 year trial period]
- Control of vascular risk factors (VRF) [Time frame: Assessed at the end of the 1 and 2 year trial period]
- Vascular events incidence [Time frame: Assessed at the end of the 1 and 2 year trial period]
- Predictors of vascular recurrence [Time frame: Assessed at the end of the 1 and 2 year trial period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Spain · 1 center
- Hospital Universitari Vall d'Hebron — Barcelona
Identifiers
NCT: NCT05565781 · PI20/01210