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

NCT05565781 | Recruiting DMC

• 1 other identifier: PI20/01210
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation; Cryptogenic Stroke

Keywords

Wearable Electronic Devices

Outcome Measures

Primary Outcomes (1)

• Increased probability of detecting AF

  To identify and compare prevalence rates of AF detection for the purpose of determine the clinical relevance or not of a prolonged screening process for AF. On the intervention group, patients will have a cardiac monitoring for up to 12 months. If AF is detected by ECG smartwatch, the ICM data will be analyzed by a cardiologist team and provide an ECG report to investigators in order to confirmed ECG smartwatch result.

  Assessed throughout 1 year trial period

Secondary Outcomes (5)

• Identification of Atrial Fibrillation using a ECG smartwatch

  Assessed throughout 1 year trial period

• Usability and adherence to ECG Smartwatch

  Assessed throughout 1 year trial period

• Control of vascular risk factors (VRF)

  Assessed at the end of the 1 and 2 year trial period

• Vascular events incidence

  Assessed at the end of the 1 and 2 year trial period

• Predictors of vascular recurrence

  Assessed at the end of the 1 and 2 year trial period

Study Arms (3)

ECG Smartwatch for up to 1 year

ACTIVE COMPARATOR

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)

Device: ECG smartwatch; Device: Insertable Cardiac Monitor (ICM)

Holter monitoring for up to 1 year

ACTIVE COMPARATOR

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

Device: External ECG Monitoring

Control group

OTHER

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

Device: External ECG Monitoring

Interventions

ECG smartwatch DEVICE

Testing ECG smartwatch to detect AF or potential signs of AF

ECG Smartwatch for up to 1 year

Insertable Cardiac Monitor (ICM) DEVICE

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

ECG Smartwatch for up to 1 year

External ECG Monitoring DEVICE

Regular cardiac monitor for diagnosis of AF

Control group; Holter monitoring for up to 1 year

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 4, 2022
• Study Start: March 28, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)