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

NCT05425342 | Completed

• 1 other identifier: 2020-02470
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correctly identified chest lead position (V1-V6 vs. bV1-bV6)

  1 hour

• Heart rhythm

  1 hour

• Ventricular depolarisation abnormalities

  1 hour

• Ventricular repolarisation abnormalities

  1 hour

Study Arms (1)

ECG single group

EXPERIMENTAL

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

Interventions

Smartwatch ECG DEVICE

Self-recorded 9-lead smartwatch ECGs

ECG single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant ≥ 18 years
• Ability to record a smartwatch ECG
• Written informed consent as documented by signature from the participant

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator

Study Sites (1)

Universitiy Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Jens Eckstein, MD, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group, open

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: June 21, 2022
• Study Start: December 12, 2020
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)