search
Back to results

Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Chang Gung Atrial Fibrillation Detecting Software
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring artificial intelligence

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Equal or greater than twenty years old Static 12-lead electrocardiogram of General Electric MUSE XML format file. The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500). The electrocardiogram signal is 500 Hz. The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz. Exclusion Criteria: Cases used in the model development process. Lacks any electrode. Contain any electrode lacks a segment. Misplaced leads

Sites / Locations

  • Chang Gung memorial hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Software diagnosis

Arm Description

Software diagnosis with gold standard of 3 doctors' consensus.

Outcomes

Primary Outcome Measures

Sensitivity
The rate of test results that correctly indicate the presence.

Secondary Outcome Measures

Specificity
The rate of test results that correctly indicate the absence.
Accuracy
The rate of all test results that correctly indicate.
Area Under the receiver operating characteristic Curve
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Positive predictive value
The proportions of positive results in statistics and diagnostic tests that are true positive results
Negative predictive value
The proportions of negative results in statistics and diagnostic tests that are true negative results
False positive rate
The rate of test result which wrongly indicates that a particular condition or attribute is present
False negative rate
The rate of test result which wrongly indicates that a particular condition or attribute is absent

Full Information

First Posted
May 4, 2023
Last Updated
May 14, 2023
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05872516
Brief Title
Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software
Official Title
A Study to Evaluate Accuracy and Validity of the Chang Gung Atrial Fibrillation Detecting Software
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

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
Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence electrocardiogram signal analysis software that detects whether a patient has atrial fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection software can correctly identify atrial fibrillation in patients with atrial fibrillation, and can be used to provide a reference for doctors to detect atrial fibrillation.
Detailed Description
This study is a retrospective study, and the data is from the six hospitals of Chang Gung Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram (ECG) data from the database during the period of January 1, 2006, to December 31, 2019. We created a training set and a testing set of ECG data from the CGRD. Then, we stratified and sampled ECG signals from the testing set according to the actual proportion to obtain the experimental sample. The computer first preliminarily screened and selected ECG data that met the inclusion and exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the sampled ECG data did not include exclusion criteria. The ECG data were converted into images and interpreted for the presence or absence of atrial fibrillation by three cardiologists. Their results were used as the gold standard (reference) for this study. After determining the experimental standards, the ECG signals were inputted into the Chang Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data. After the software interpretation was completed, the results were compared with the interpretations of the physicians, and the primary and secondary evaluation indicators were analyzed accordingly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
artificial intelligence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
788 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Software diagnosis
Arm Type
Experimental
Arm Description
Software diagnosis with gold standard of 3 doctors' consensus.
Intervention Type
Device
Intervention Name(s)
Chang Gung Atrial Fibrillation Detecting Software
Intervention Description
This software is expected to be used in clinical testing to interpret the static 12-lead ECG of adults who are over 20 years old and suspected of having atrial fibrillation, detect whether there is a signal of atrial fibrillation, and output the results for clinicians Near-instant auxiliary diagnostic use.
Primary Outcome Measure Information:
Title
Sensitivity
Description
The rate of test results that correctly indicate the presence.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Specificity
Description
The rate of test results that correctly indicate the absence.
Time Frame
baseline
Title
Accuracy
Description
The rate of all test results that correctly indicate.
Time Frame
baseline
Title
Area Under the receiver operating characteristic Curve
Description
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Time Frame
baseline
Title
Positive predictive value
Description
The proportions of positive results in statistics and diagnostic tests that are true positive results
Time Frame
baseline
Title
Negative predictive value
Description
The proportions of negative results in statistics and diagnostic tests that are true negative results
Time Frame
baseline
Title
False positive rate
Description
The rate of test result which wrongly indicates that a particular condition or attribute is present
Time Frame
baseline
Title
False negative rate
Description
The rate of test result which wrongly indicates that a particular condition or attribute is absent
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Equal or greater than twenty years old Static 12-lead electrocardiogram of General Electric MUSE XML format file. The data comes from the static 12-lead electrocardiogram device of General Electric (model MAC5500). The electrocardiogram signal is 500 Hz. The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz. Exclusion Criteria: Cases used in the model development process. Lacks any electrode. Contain any electrode lacks a segment. Misplaced leads
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Fu Kuo, MD/Ph.D
Organizational Affiliation
Associate Professor and Director Division of Rheumatology
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung memorial hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17604299
Citation
Mant J, Fitzmaurice DA, Hobbs FD, Jowett S, Murray ET, Holder R, Davies M, Lip GY. Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial. BMJ. 2007 Aug 25;335(7616):380. doi: 10.1136/bmj.39227.551713.AE. Epub 2007 Jun 29.
Results Reference
background
PubMed Identifier
30088016
Citation
US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Atrial Fibrillation With Electrocardiography: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 7;320(5):478-484. doi: 10.1001/jama.2018.10321.
Results Reference
background
PubMed Identifier
32393588
Citation
Wong KC, Klimis H, Lowres N, von Huben A, Marschner S, Chow CK. Diagnostic accuracy of handheld electrocardiogram devices in detecting atrial fibrillation in adults in community versus hospital settings: a systematic review and meta-analysis. Heart. 2020 Aug;106(16):1211-1217. doi: 10.1136/heartjnl-2020-316611. Epub 2020 May 11.
Results Reference
background
PubMed Identifier
32860505
Citation
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194.
Results Reference
background

Learn more about this trial

Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software

We'll reach out to this number within 24 hrs