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SMARTHEART Validation Study

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ClinicalTrials.gov Identifier: NCT04755582
Recruitment Status : Not yet recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Study Description
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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
Cardiovascular Diseases

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
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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from cardiology wards across the University Hospitals of Leicester trust.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755582


Contacts
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Contact: Zakariyya Vali 01162502366 z.vali@le.ac.uk

Locations
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United Kingdom
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP
Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: G. Andre Ng University of Leicester
More Information
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04755582    
Other Study ID Numbers: 0693
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cardiovascular Diseases