SMARTHEART Validation Study

NCT ID: NCT04755582

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G. Andre Ng

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

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Glenfield Hospital, University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Zakariyya Vali

Role: CONTACT

01162502366

Other Identifiers

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0693

Identifier Type: -

Identifier Source: org_study_id

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