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SMARTHEART Validation Study

Sponsor
University of Leicester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04755582
Collaborator
(none)
128
Enrollment
1
Location
18
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Assess the effect of the following on the accuracy of the recorded ECG compared to a gold standard ECG:

    • Posture or position of the patient

    • Movement

    • Amount of hair on the ECG site

    • Skin condition (tone/dryness) Ability to detect a paced rhythm accurately A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    128 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    SMARTHEART Validation Study. A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices [2 hours]

      To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

    Secondary Outcome Measures

    1. Assessing the effects on the ECG of: - Posture or position of the patient [2 hours]

      Assessment of changes to the ECG signal due to posture or position of the patient

    2. Assessing the effects on the ECG of: • Movement [2 hours]

      Assessment of changes to the ECG signal due to movement of the patient

    3. Assessing the effects on the ECG of: • Amount of hair on the ECG site [12 months]

      Assessment of changes to the ECG signal due to amount of hair on the site of ECG electrode positions

    4. Assessing the effects on the ECG of: • Skin condition (tone/dryness) [12 months]

      Assessment of changes to the ECG signal due to different skin conditions on the site of ECG electrode positions

    5. Ability to detect a paced rhythm accurately. [2 hours]

      Assessment of ability of ECG device to detect paced ECG complexes or pacing spikes

    6. A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant is willing and able to give informed consent for participation in the study.

    • Must have an adequate understanding of written and spoken English

    • Able (in the Investigators opinion) and willing to comply with study requirements.

    • Must be over 18 years of age

    • Must be deemed clinically stable by their direct care team.

    Exclusion Criteria:

    • Subjects who do not have an adequate understanding of written and spoken English

    • Patients who are medically unstable, as defined by the patient's direct care team.

    • Patients who are unable to give informed consent

    • Patients who are deemed clinically unstable by their direct care team

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glenfield Hospital, University Hospitals of Leicester NHS Trust Leicester Leicestershire United Kingdom LE3 9QP

    Sponsors and Collaborators

    • University of Leicester

    Investigators

    • Principal Investigator: G. Andre Ng, University of Leicester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT04755582
    Other Study ID Numbers:
    • 0693
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Leicester
    wearable ecg
    electrocardiogram
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Feb 16, 2021