Clinical trial NCT05425342: iECG: Recording Chest Leads Using a Smartwatch With a Digital Image Processing Algorithm
Official title: iECG: A Feasibility Study for Recording Chest Leads Using a Smartwatch Coupled With a Digital Image Processing Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrocardiogram
Keywords: 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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2022-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group, open
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correctly recorded smartwatch ECG lead by patient
timeFrame: 1 hour
Secondary outcomes:
measure: Correctly identified chest lead position (V1-V6 vs. bV1-bV6)
timeFrame: 1 hour
measure: Heart rhythm
timeFrame: 1 hour
measure: Ventricular depolarisation abnormalities
timeFrame: 1 hour
measure: Ventricular repolarisation abnormalities
timeFrame: 1 hour
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitiy Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: