SMARTHEART Validation Study

SMARTHEART Validation Study. A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 128

Contacts and Locations

• Study Contact: Name: Zakariyya Vali; Phone Number: 01162502366; Email: z.vali@le.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Glenfield Hospital, University Hospitals of Leicester NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from cardiology wards across the University Hospitals of Leicester trust.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices	To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the effects on the ECG of: - Posture or position of the patient	Assessment of changes to the ECG signal due to posture or position of the patient	2 hours
Assessing the effects on the ECG of: • Movement	Assessment of changes to the ECG signal due to movement of the patient	2 hours
Assessing the effects on the ECG of: • Amount of hair on the ECG site	Assessment of changes to the ECG signal due to amount of hair on the site of ECG electrode positions	12 months
Assessing the effects on the ECG of: • Skin condition (tone/dryness)	Assessment of changes to the ECG signal due to different skin conditions on the site of ECG electrode positions	12 months
Ability to detect a paced rhythm accurately.	Assessment of ability of ECG device to detect paced ECG complexes or pacing spikes	2 hours
A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device.		12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: electrocardiogram; wearable ecg
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 0693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No