ElectrocardiogramiECGNCT05425342
iECG: Recording Chest Leads Using a Smartwatch With a Digital Image Processing Algorithm
A study testing Smartwatch ECG in people with Electrocardiogram, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electrocardiogram
- What is being tested?
- Smartwatch ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Dec 2020to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant ≥ 18 years
- Ability to record a smartwatch ECG
- Written informed consent as documented by signature from the participant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitiy Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: iECG: A Feasibility Study for Recording Chest Leads Using a Smartwatch Coupled With a Digital Image Processing Algorithm
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.
Read the 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
- Being tested
- Smartwatch ECG
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch ECGDevice
Self-recorded 9-lead smartwatch ECGs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Smartwatch ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
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)
Measured: 1 hour
Heart rhythm
ECGs will be assessed for rhythm (eg. sinus rihythm, atrial fibrillation) by two board certified cardiologists
Measured: 1 hour
Ventricular depolarisation abnormalities
ECGs will be assessed for ventricular depolarisation abnormalities (eg. bandle branch blocks) by two board certified cardiologists
Measured: 1 hour
Ventricular repolarisation abnormalities
ECGs will be assessed for ventricular repolarisation abnormalities (eg. ST elevation) by two board certified cardiologists
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start12 Dec 2020
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrocardiogramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, open
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425342
- Sponsor's protocol ID
- 2020-02470
- Acronym
- iECG
- Status last verified
- Jun 2022
- First submitted
- 8 Dec 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iECG: A Feasibility Study for Recording Chest Leads Using a Smartwatch Coupled With a Digital Image Processing Algorithm
- ClinicalTrials.gov ID
- NCT05425342
- Acronym / sponsor ID
- iECG / 2020-02470
- Conditions
- Electrocardiogram
- Keywords
- Electrocardiogram ECG, Smartwatch ECG, Wearables, eHealth, medical image processing, machine learning, self health check-up, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, open
| Arm | Type | Receives |
|---|---|---|
| ECG single group | Experimental | Device: Smartwatch ECGPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant ≥ 18 years
- Ability to record a smartwatch ECG
- Written informed consent as documented by signature from the participant
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch ECGSelf-recorded 9-lead smartwatch ECGs | Device | ECG single group |
Primary outcome
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.
4 secondary outcomes
Correctly identified chest lead position (V1-V6 vs. bV1-bV6)
Time frame: 1 hour
Heart rhythm
Time frame: 1 hour
Ventricular depolarisation abnormalities
Time frame: 1 hour
Ventricular repolarisation abnormalities
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, MD, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch ECG in people with Electrocardiogram, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctly recorded smartwatch ECG lead by patient (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.