iECG: Recording Chest Leads Using a Smartwatch With a Digital Image Processing Algorithm

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of a new method for self-recordable ECGs using a smartwatch coupled with an image processing algorithm. The long-term goal of this project is to establish such a method and to potentially integrate it into telemedical care.

Detailed Description
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There is an increasing availability of smartwatches worldwide. Health-related features of these wearables such as heart rate and -rhythm analysis have become increasingly recognised. Some smartwatches are capable of recording an electrocardiogram (ECG) which yields important information about electrical heart activity. Recording a complete ECG with a smartwatch is challenging if the user has no prior medical experience. In this feasibility study we introduce a novel image processing tool that instructs the user to record an ECG using the front camera of an iPad. In a second step, a standard ECG will be recorded by medical staff. The ECGs will then be compared by two board certified cardiologists. The aim of the study is to evaluate the feasibility of self-recorded smartwatch ECGs. If this method can be established, it could markedly expand the diagnostic options for heart and vascular diseases.

Official Title
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iECG: A Feasibility Study for Recording Chest Leads Using a Smartwatch Coupled With a Digital Image Processing Algorithm

Conditions
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Electrocardiogram

Intervention / Treatment
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* Device: Smartwatch ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant ≥ 18 years Ability to record a smartwatch ECG Written informed consent as documented by signature from the participant Exclusion Criteria: Smartwatch ECG or conventional ECG cannot be recorded due to comprehensible reasons (allergic reactions, wounds, etc.) Unable or not willing to sign informed consent Significant mental or cognitive impairment that could interfere with the measurements (e.g. delirium, acute psychotic episode, etc., assessed by recruiting physician) · Prior knowledge or experience in recording ECGs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: single group, open
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECG single group<br>Patients will be instructed how to record an ECG on a smartwatch using the front camera of an iPad. In a second step, a standard ECG will be recorded by medical staff. The ECGs will then be compared by two board certified cardiologists | Device: Smartwatch ECG<br>* Self-recorded 9-lead smartwatch ECGs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctly recorded smartwatch ECG lead by patient | The number of correctly recorded limb (I, II, III) and chest leads (bV1-bV6 where the letter b denotes bipolar chest leads) will be assessed. A correctly recorded lead is defined as a complete, 30-second long bipolar electrical signal obtained by the patient with the smartwatch afterpreviously being instructed. The number of correctly recorded smartwatch ECG leads is a measure to determine the feasibility of the method. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correctly identified chest lead position (V1-V6 vs. bV1-bV6) | Chest ECG leads obtained with a traditional ECG (V1-V6) will be compared with the ones recorded with a smartwatch (bV1-bV6). The percentage of correctly assigned chest leads will be assessed (e.g. V4 is expected to be assigned to bV4) | 1 hour | 
| Heart rhythm | ECGs will be assessed for rhythm (eg. sinus rihythm, atrial fibrillation) by two board certified cardiologists | 1 hour | 
| Ventricular depolarisation abnormalities | ECGs will be assessed for ventricular depolarisation abnormalities (eg. bandle branch blocks) by two board certified cardiologists | 1 hour | 
| Ventricular repolarisation abnormalities | ECGs will be assessed for ventricular repolarisation abnormalities (eg. ST elevation) by two board certified cardiologists | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrocardiogram ECG, Smartwatch ECG, Wearables, eHealth, medical image processing, machine learning, self health check-up, telemedicine, digital medicine, bipolar chest leads, electrical signal quality, self-recordable smartwatch ECG, heart rhythm, cardiac pathology in ECG