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Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers

Sponsor
Medical University of Lodz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05206825
Collaborator
(none)
300
Enrollment
1
Location
22.9
Anticipated Duration (Months)
13.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.

    ECG evaluation will include: rhythm description, measurements of mean RR, PR, QRS, QT, QTc and ST-T description. Additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ECG and approximate from mobile ECG recordings.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers
    Actual Study Start Date :
    Jan 2, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. ECG Tracing Quality [Once: Day 0-3 after entry to the study.]

      Evaluation of quality of ECG tracings obtained with different electrocardiographs

    2. Cardiac Rhythm Determination [Once: Day 0-3 after entry to the study.]

      Defining a rhythm of the patient based on recorder tracings.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients with indication for electrocardiography

    • Informed consent to participate in the study

    • The possibility of self-registration of a mobile ECG (no physical and mental restrictions)

    Exclusion Criteria:

    • Not willing or incapable to give written informed consent.

    • Lack of willingness to cooperate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Electrocardiology Medical University of Lodz Lodz Poland 93-216

    Sponsors and Collaborators

    • Medical University of Lodz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Lodz
    ClinicalTrials.gov Identifier:
    NCT05206825
    Other Study ID Numbers:
    • RNN/172/20/KE
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Lodz
    Electrocardiogram
    Mobile ECG
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac

    Study Results

    No Results Posted as of Jul 19, 2022