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

NCT ID: NCT05425342

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-12
• Study Completion Date: 2021-03-23

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.

Conditions

Electrocardiogram

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Smartwatch ECG

Intervention Type: DEVICE

Self-recorded 9-lead smartwatch ECGs

Interventions

Smartwatch ECG

Self-recorded 9-lead smartwatch ECGs

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Eckstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Universitiy Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2020-02470

Identifier Type: -

Identifier Source: org_study_id