Clinical trial NCT05565781: Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke
Official title: Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Cryptogenic Stroke
Keywords: Wearable Electronic Devices
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Increased probability of detecting AF
timeFrame: Assessed throughout 1 year trial period
Secondary outcomes:
measure: Identification of Atrial Fibrillation using a ECG smartwatch
timeFrame: Assessed throughout 1 year trial period
measure: Usability and adherence to ECG Smartwatch
timeFrame: Assessed throughout 1 year trial period
measure: Control of vascular risk factors (VRF)
timeFrame: Assessed at the end of the 1 and 2 year trial period
measure: Vascular events incidence
timeFrame: Assessed at the end of the 1 and 2 year trial period
measure: Predictors of vascular recurrence
timeFrame: Assessed at the end of the 1 and 2 year trial period
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Cataluña
Study officials:
References: