Cardiovascular DiseasesNCT05469542
Everbeat Ring ECG Clinical Concordance Study
An observational study of Cardiovascular Diseases, run by Grektek Inc. at 1 site in United States.
Trial summary
This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Everbeat Ring
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 20 Sep 2022
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-90 presenting for a routine internal medicine or cardiology clinic visit
Who may be able to join
- Males or females aged 18 to 90 years.
- Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG)
- Resting heart rate between 50 to 120 beats per minute (BPM).
Who cannot join
- Inability to wear the everbeat ring.
- Prior history of movement disorders including Parkinson's or benign tremors.
- Prior history of allergic skin reactions to metal including stainless steel.
Trial locations and contacts
1 site in 1 country.
United States1 site
BKLYNCardio
Brooklyn, New York, 11217
Glenis Strachan, MD, 718-237-4067, gasb@gmail.com
Charles Pollack, MD
About this study
Official title: Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.
- Conditions
- Cardiovascular Diseases
- Being tested
- Everbeat Ring
- Keywords
- ECG, Wearables, Electrocardiography
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everbeat RingDevice
The primary objective of this study is to assess the concordance of specific ECG parameters obtained in the everbeat nine-lead ECG waveform with those obtained in the comparable leads from a standard 12-lead ECG recorder.
What is being measured
The primary outcome is the main question the study is designed to answer.
R-wave Amplitude
R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm
Measured: 50 days
ST-segment
Concordance in ST-segment deviation from the TP segment if present in mm
Measured: 50 Days
Blinded Cardiologist Review
Identify the first six consecutive distinct readable PQRST complexes without artifacts that match between the strips for evaluation. Each reviewer will assign a pass/fail to the strips by visually assessing all 6 PQRST complexes. A "pass" is given when the morphology of the PQRST complexes appears to overlay to the unaided eye. A measurement of the R amplitude from the isoelectric baseline to the nearest millimeter for the first two QRS complexes in both the reference strip and everbeat strip. The reviewers will be blinded to the identity of the reference strip and everbeat strip.
Measured: 50 Days
Secondary outcomes (1)
User acceptance survey
To assess the ease of use of the everbeat ring in a random selection of users.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grektek Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469542
- Sponsor's protocol ID
- Pro00064656
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
- ClinicalTrials.gov ID
- NCT05469542
- Acronym / sponsor ID
- Pro00064656
- Conditions
- Cardiovascular Diseases
- Keywords
- ECG, Wearables, Electrocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Grektek Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 21 Jul 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.
This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-90 presenting for a routine internal medicine or cardiology clinic visit
Key inclusion criteria (3 listed)
- Males or females aged 18 to 90 years.
- Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG)
- Resting heart rate between 50 to 120 beats per minute (BPM).
Key exclusion criteria (3 listed)
- Inability to wear the everbeat ring.
- Prior history of movement disorders including Parkinson's or benign tremors.
- Prior history of allergic skin reactions to metal including stainless steel.
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 |
|---|---|---|
| Everbeat RingThe primary objective of this study is to assess the concordance of specific ECG parameters obtained in the everbeat nine-lead ECG waveform with those obtained in the comparable leads from a standard 12-lead ECG recorder. | Device | – |
Primary outcome
R-wave Amplitude
Time frame: 50 days
R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm
ST-segment
Time frame: 50 Days
Concordance in ST-segment deviation from the TP segment if present in mm
Blinded Cardiologist Review
Time frame: 50 Days
Identify the first six consecutive distinct readable PQRST complexes without artifacts that match between the strips for evaluation. Each reviewer will assign a pass/fail to the strips by visually assessing all 6 PQRST complexes. A "pass" is given when the morphology of the PQRST complexes appears to overlay to the unaided eye. A measurement of the R amplitude from the isoelectric baseline to the nearest millimeter for the first two QRS complexes in both the reference strip and everbeat strip. The reviewers will be blinded to the identity of the reference strip and everbeat strip.
1 secondary outcome
User acceptance survey
Time frame: 50 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Grektek Inc. at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-wave Amplitude (time frame: 50 days). The study lists 3 primary outcomes in all. 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 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.