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Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor

6. juni 2022 oppdatert av: PulseOn Oy
The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.

During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:

  1. Scheduled recording four times a day
  2. In case of suspecting arrhythmic event, i.e. feeling symptoms
  3. In case the wrist device instructs to perform a recording by vibrating and showing an LED light

The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.

Studietype

Intervensjonell

Registrering (Forventet)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Finland
      • Tampere, Finland
        • Rekruttering
        • Tampere Heart Hospital
        • Ta kontakt med:
          • Research coordinator at Heart Hospital
          • Telefonnummer: +358417306125

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria for the main study group:

  • At least 65 years of age
  • Self-assessed ability to use the study devices
  • Ability to give informed consent
  • Volunteering for the study

Inclusion criteria for the active endurance athlete group:

  • Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon…) and currently an average amount of training of at least 10 hours a week.
  • Age: ≥ 50 years
  • Self-assessed ability to use the study devices
  • Ability to give informed consent
  • Volunteering for the study

Exclusion Criteria for both groups:

  • Cardiac pacemaker
  • Earlier diagnosis of atrial fibrillation
  • Inability to give informed consent
  • Denial

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Main study group
Normal subjects of at least 65 years of age
Enhet: PulseOn Arrhythmia Monitor device
Wearing of the wrist device for a period of two weeks
Eksperimentell: Endurance athlete group
Group consists of active endurance athletes of at least 50 years of age
Enhet: PulseOn Arrhythmia Monitor device
Wearing of the wrist device for a period of two weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic performance improvement with continuous optical measurement
Tidsramme: Duration of patient measurement, i.e. two weeks
Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.
Duration of patient measurement, i.e. two weeks
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
Tidsramme: Duration of patient measurement, i.e. two weeks
Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.
Duration of patient measurement, i.e. two weeks
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
Tidsramme: Duration of patient measurement, i.e. two weeks
The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".
Duration of patient measurement, i.e. two weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.
Tidsramme: Duration of patient measurement, i.e. two weeks
The visual ECG-based rhythm annotation made by a cardiologist is compared with simultaneous PPG-algorithm alarm state. The incidence of notifications for other arrhythmias than atrial fibrilation is reported.
Duration of patient measurement, i.e. two weeks
Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.
Tidsramme: Duration of patient measurement, i.e. two weeks
Evaluation is done by comparing the atrial fibrillation detection outcome when considering only the PPG-triggered and symptom-based ECG measurements or when considering also the scheduled ECG measurements. The outcome parameter is the number of subjects that would have been left undetected if the scheduled ECG measurements were not taken.
Duration of patient measurement, i.e. two weeks
Feedback about the usability of the evaluated solution from study subjects.
Tidsramme: At the end of the 2-week measurement period
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the wrist device, understandability of the user interface, suitability of the user materials, and unobtrusiveness.
At the end of the 2-week measurement period
Feedback about the usability of the evaluated solution from study personnel.
Tidsramme: At the end of the study i.e. the end of 2022.
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.
At the end of the study i.e. the end of 2022.
Quality of the measured ECG signals
Tidsramme: Duration of patient measurement, i.e. two weeks
Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.
Duration of patient measurement, i.e. two weeks
Assessment of the subjects' adherence in using the solution.
Tidsramme: Duration of patient measurement, i.e. two weeks
Analysis of how well the participants will follow the study protocol and do the participants register their ECG in correlation with the wrist device notification. The outcome parameter is the percentage of scheduled and PPG-based notifications to take an ECG measurement and the variation of the percentage between the subjects.
Duration of patient measurement, i.e. two weeks
Benefit of optical measurement for the speed of detecting atrial fibrillation
Tidsramme: Duration of patient measurement, i.e. two weeks
Comparison of the time to the first detection of atrial fibrillation or other arrhythmia when considering PPG-triggered ECG measurements or when considering the scheduled ECG measurements.
Duration of patient measurement, i.e. two weeks
Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
Tidsramme: Duration of patient measurement, i.e. two weeks
The automated assessment done for the 30-second ECG recordings is compared with the visual assessment to calculate the sensitivity and specificity for each rhythm category.
Duration of patient measurement, i.e. two weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

PulseOn Oy

Samarbeidspartnere

TAYS Sydänkeskus Oy
Atostek Oy

Etterforskere

  • Hovedetterforsker: Vesa Virtanen, PhD (med), Heart Hospital of Tampere University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. mai 2022

Primær fullføring (Forventet)

31. desember 2022

Studiet fullført (Forventet)

31. desember 2022

Datoer for studieregistrering

Først innsendt

18. november 2021

Først innsendt som oppfylte QC-kriteriene

18. januar 2022

Først lagt ut (Faktiske)

19. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AinoScreening

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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