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

Electrocardiogram Clinical Trial

— iECG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425342
• Other study ID #: 2020-02470
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: March 23, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electrocardiogram

Intervention

Device:
• Smartwatch ECG
Self-recorded 9-lead smartwatch ECGs

Locations

Country	Name	City	State
Switzerland	Universitiy Hospital Basel	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Heart rhythm	ECGs will be assessed for rhythm (eg. sinus rihythm, atrial fibrillation) by two board certified cardiologists	1 hour
Secondary	Ventricular depolarisation abnormalities	ECGs will be assessed for ventricular depolarisation abnormalities (eg. bandle branch blocks) by two board certified cardiologists	1 hour
Secondary	Ventricular repolarisation abnormalities	ECGs will be assessed for ventricular repolarisation abnormalities (eg. ST elevation) by two board certified cardiologists	1 hour