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

NCT ID: NCT05565781

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2026-09-01

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.

Conditions

Paroxysmal Atrial Fibrillation; Cryptogenic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

ECG Smartwatch for up to 1 year

Cardiac monitoring with a smartwatch that support the recording of a single-lead electrocardiogram (ECG) over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM)

Group Type: ACTIVE_COMPARATOR

ECG smartwatch

Intervention Type: DEVICE

Testing ECG smartwatch to detect AF or potential signs of AF

Insertable Cardiac Monitor (ICM)

Intervention Type: DEVICE

Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)

Holter monitoring for up to 1 year

Cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke and 15 additional days of extended use every 3 months up to 1 year

Group Type: ACTIVE_COMPARATOR

External ECG Monitoring

Intervention Type: DEVICE

Regular cardiac monitor for diagnosis of AF

Control group

Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke

Group Type: OTHER

External ECG Monitoring

Intervention Type: DEVICE

Regular cardiac monitor for diagnosis of AF

Interventions

ECG smartwatch

Testing ECG smartwatch to detect AF or potential signs of AF

Intervention Type: DEVICE

Insertable Cardiac Monitor (ICM)

Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)

Intervention Type: DEVICE

External ECG Monitoring

Regular cardiac monitor for diagnosis of AF

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Jorge Pagola, Neurologist

Role: primary

jpagola@vhebron.net

932746000 ext. 6364

Other Identifiers

PI20/01210

Identifier Type: -

Identifier Source: org_study_id