SMARTHEART Validation Study
1 other identifier
observational
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 16, 2021
February 1, 2021
1.5 years
February 5, 2021
February 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Assessing the effects on the ECG of: - Posture or position of the patient
2 hours
Assessing the effects on the ECG of: • Movement
2 hours
Assessing the effects on the ECG of: • Amount of hair on the ECG site
12 months
Assessing the effects on the ECG of: • Skin condition (tone/dryness)
12 months
Ability to detect a paced rhythm accurately.
2 hours
- +1 more secondary outcomes
Eligibility Criteria
Participants will be recruited from cardiology wards across the University Hospitals of Leicester trust.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP, United Kingdom
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
G. Andre Ng
University of Leicester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 16, 2021
Study Start
July 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 16, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share