Smartwatch and External Holter Monitoring to Detect Atrial Fibrillation in Patients With Cryptogenic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • ECG smartwatch
  • Insertable Cardiac Monitor (ICM)
  • External ECG Monitoring

Treatment groups

100 Participants
are divided into 3 treatment groups