EVALECGcardio Study

NCT ID: NCT04468477

Last Updated: 2020-07-13

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

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2021-05-21

Brief Summary

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ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.

Detailed Description

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The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Conditions

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Cardiac Arrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients attending cardiac outpatient clinic

Group Type ACTIVE_COMPARATOR

6 Lead ECG

Intervention Type DEVICE

Patients will be assessed with the Kardiamobile device.

Interventions

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6 Lead ECG

Patients will be assessed with the Kardiamobile device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)

Exclusion Criteria

* Patients who do not consent to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Muzahir Tayebjee, MBChB MRCP MD

Role: primary

Other Identifiers

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CD20/130832

Identifier Type: -

Identifier Source: org_study_id

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