SMARTHEART Validation Study

• Conditions: Cardiovascular Diseases

• Registration Number: NCT04755582
• Lead Sponsor: University of Leicester

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.

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 Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16
• Study Start: 2021-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Ability to detect a paced rhythm accurately.	2 hours	Assessment of ability of ECG device to detect paced ECG complexes or pacing spikes
Assessing the effects on the ECG of: • Movement	2 hours	Assessment of changes to the ECG signal due to movement of the patient
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
A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device.	12 months

Trial Locations

Locations (1)

Glenfield Hospital, University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, Leicestershire, United Kingdom