SMARTHEART Validation Study | NCT04755582

Studies
SMARTHEART Validation Study

NCT04755582

Sponsor

University of Leicester

Status

Unknown status

Last Update Posted

Feb 16, 2021Actual

Enrollment

128Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zakariyya Vali	Contact	01162502366		z.vali@le.ac.uk

Overall Officials

Name	Affiliation	Role
G. Andre Ng	University of Leicester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glenfield Hospital, University Hospitals of Leicester NHS Trust		Leicester	Leicestershire	LE3 9QP	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided