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

University Hospital, Basel, Switzerland50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Electrocardiogram

Interventions

Smartwatch ECGDEVICE

Self-recorded 9-lead smartwatch ECGs

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitiy Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Secondary Outcomes

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)

Time frame: 1 hour

Heart rhythm

ECGs will be assessed for rhythm (eg. sinus rihythm, atrial fibrillation) by two board certified cardiologists

Time frame: 1 hour

Ventricular depolarisation abnormalities

ECGs will be assessed for ventricular depolarisation abnormalities (eg. bandle branch blocks) by two board certified cardiologists

Time frame: 1 hour

Ventricular repolarisation abnormalities

ECGs will be assessed for ventricular repolarisation abnormalities (eg. ST elevation) by two board certified cardiologists

Time frame: 1 hour

Data from ClinicalTrials.gov

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