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Clinical Trials/NCT05425342
NCT05425342
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country50 target enrollmentDecember 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Electrocardiogram
Sponsor
University Hospital, Basel, Switzerland
Enrollment
50
Locations
1
Primary Endpoint
Correctly recorded smartwatch ECG lead by patient
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2020
End Date
March 23, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Correctly recorded smartwatch ECG lead by patient

Time Frame: 1 hour

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.

Secondary Outcomes

  • Ventricular repolarisation abnormalities(1 hour)
  • Correctly identified chest lead position (V1-V6 vs. bV1-bV6)(1 hour)
  • Heart rhythm(1 hour)
  • Ventricular depolarisation abnormalities(1 hour)

Study Sites (1)

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