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

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

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.

Study Overview

• Status: Completed
• Conditions: Electrocardiogram
• Intervention / Treatment: Device: Smartwatch ECG

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitiy Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECG single group; 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; Self-recorded 9-lead smartwatch ECGs

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): March 23, 2021
• Study Completion (Actual): March 23, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: machine learning; telemedicine; eHealth; Wearables; digital medicine; Electrocardiogram ECG; Smartwatch ECG; medical image processing; self health check-up; bipolar chest leads; electrical signal quality; self-recordable smartwatch ECG; heart rhythm; cardiac pathology in ECG
• Other Study ID Numbers: 2020-02470

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