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

Impact of Non-invasive Remote Monitoring Via Wearable Technologies for Detection of Atrial Fibrillation in Patients With Cryptogenic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation; Cryptogenic Stroke
• Intervention / Treatment: Device: ECG smartwatch; Device: Insertable Cardiac Monitor (ICM); Device: External ECG Monitoring

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall D'Hebron
      • Contact: Jorge Pagola, Neurologist; Phone Number: 6364 932746000; Email: jpagola@vhebron.net
      • Principal Investigator: Jorge Pagola, Neurologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ECG Smartwatch for up to 1 year; 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)	Device: ECG smartwatch; Testing ECG smartwatch; Device: Insertable Cardiac Monitor (ICM); Gold-standard cardiac monitor for comparison of testing device (ECG smartwatch)
ACTIVE_COMPARATOR: 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	Device: External ECG Monitoring; Regular cardiac monitor for diagnosis of atrial fibrillation
OTHER: Control group; Regular cardiac monitoring with an external holter device for 30 days after the acute phase of cryptogenic stroke	Device: External ECG Monitoring; Regular cardiac monitor for diagnosis of atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of Atrial Fibrillation using a ECG smartwatch	Episodes of atrial fibrillation detected by the ECG smartwatch will be compared to the gold-standard cardiac monitor	Assessed throughout 1 year trial period
Usability and adherence to ECG Smartwatch	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.	Assessed throughout 1 year trial period
Control of vascular risk factors (VRF)	To describe and compare the percentage of adequate control of VRFs among patients in each study group. VRFs metrics are defined according to the AHA Life Simple 7 factors. Ideal metrics were defined as follows: (1) Smoking status: never or former smoker; (2) BMI: <25 kg/m2; (3) Physical activity: ≥150 min/wk of moderate-intensity physical activity; (4) Healthy diet: 4 or 5 fruits/vegetables per day; (5) Total cholesterol <200 mg/dL; (6) Blood pressure <120/80 mm Hg; (7) Fasting glucose <100 mg/dL.	Assessed at the end of the 1 and 2 year trial period
Vascular events incidence	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	Assessed at the end of the 1 and 2 year trial period
Predictors of vascular recurrence	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.	Assessed at the end of the 1 and 2 year trial period

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (ACTUAL): October 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Wearable Electronic Devices
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: PI20/01210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No