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

Not Applicable

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation; Cryptogenic Stroke
• Interventions: Device: External ECG Monitoring; Device: ECG smartwatch; Device: Insertable Cardiac Monitor (ICM)

• Registration Number: NCT05565781
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	External ECG Monitoring	Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke
ECG Smartwatch for up to 1 year	ECG smartwatch	Cardiac monitoring with an ECG Smartwatch over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM)
ECG Smartwatch for up to 1 year	Insertable Cardiac Monitor (ICM)	Cardiac monitoring with an ECG Smartwatch over 1 year after the acute phase of cryptogenic stroke. Simultaneously, a continuous cardiac monitoring will be performed using an Insertable Cardiac Monitor (ICM)
Holter monitoring for up to 1 year	External ECG Monitoring	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

Primary Outcome Measures

Name	Time	Method
Increased probability of detecting AF	Assessed throughout 1 year trial period	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.

Secondary Outcome Measures

Name	Time	Method
Identification of Atrial Fibrillation using a ECG smartwatch	Assessed throughout 1 year trial period	Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor
Usability and adherence to ECG Smartwatch	Assessed throughout 1 year trial period	To evaluate the usability to the use of the ECG Smartwatch through the System usability scale (SUS) and self-reported of likes or dislikes encountered with wearable.
Control of vascular risk factors (VRF)	Assessed at the end of the 1 and 2 year trial period	To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the American Heart Association's recommendations, including blood pressure, lipids, glucose, body mass index, nicotine exposure, diet, physical activity, and sleep health. Sub-study analysis will be perform considering data from smartwatch such as sleep, physical activity, and other health behavior.
Vascular events incidence	Assessed at the end of the 1 and 2 year trial period	To describe the vascular events defined as recurrence of stroke, the incidence of cerebral hemorrhage, heart failure, myocardial infarction, or vascular death in each study group
Predictors of vascular recurrence	Assessed at the end of the 1 and 2 year trial period	To identify predictors of vascular recurrence (recurrent stroke, cerebral hemorrhage, heart failure, myocardial infarction, or vascular death) in each study group. Predictors of vascular recurrence included sociodemographic data such as age, sex and education level; BMI (kg/m2); history of diabetes mellitus; LDL-cholesterol and medications, such as the use of anti-hypertensive medications, lipid-lowering medications, and antiplatelet therapy. Also clinical symptoms, neuroimagen and ECG parameters will be included in the analysis.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Cataluña, Spain