Back to resultsEVALECGcardio Study
Primary Purpose
Cardiac Arrhythmia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
6 Lead ECG
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrhythmia
Eligibility Criteria
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
Sites / Locations
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Patients attending cardiac outpatient clinic
Arm Description
Outcomes
Primary Outcome Measures
Difference between the 6 lead and the 12 lead Electrocardiogram
Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.
Secondary Outcome Measures
Full Information
NCT ID
NCT04468477
First Posted
July 8, 2020
Last Updated
July 8, 2020
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04468477
Brief Title
EVALECGcardio Study
Official Title
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
May 21, 2021 (Anticipated)
Study Completion Date
May 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients attending cardiac outpatient clinic
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
6 Lead ECG
Intervention Description
Patients will be assessed with the Kardiamobile device.
Primary Outcome Measure Information:
Title
Difference between the 6 lead and the 12 lead Electrocardiogram
Description
Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muzahir Tayebjee, MBChB MRCP MD
Email
muzahir.tayebjee@nhs.net
12. IPD Sharing Statement
Learn more about this trial
EVALECGcardio Study
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