A Study to Evaluate Accuracy and Validity of the "Chang Gung" Ventricular Systolic Dysfunction Screening Software

NCT05861115 | Completed

• 1 other identifier: 202200402B0C602
• Study Type: interventional
• Target: 1,172
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test a software tool called the "Chang Gung" Ventricular Systolic Dysfunction screening software, which uses a 12-lead electrocardiogram to determine if a patient has left ventricular systolic dysfunction. The goal is to determine if the software can accurately identify patients with this condition, which would help doctors diagnose and treat it more effectively. The trial will involve using the software on patients and comparing its results to those obtained through echocardiograms, which are currently the gold standard for diagnosing left ventricular systolic dysfunction. Only patients who meet specific eligibility criteria will be able to participate in the trial, and the software will be administered by trained healthcare professionals. The study will help determine if the software is a useful tool for diagnosing left ventricular systolic dysfunction, which could lead to earlier diagnosis and better outcomes for patients. The research team will collect and analyze data on the accuracy of the software and its usability in clinical practice. Overall, this study will provide important information for doctors and patients about a new tool for diagnosing left ventricular systolic dysfunction.

Conditions

Left Ventricular Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  The rate of test results that correctly indicate the presence.

  baseline

Secondary Outcomes (7)

• Specificity

  Baseline

• Accuracy

  Baseline

• Area Under the receiver operating characteristic Curve

  Baseline

• Positive predictive value

  Baseline

• Negative predictive value

  Baseline

Study Arms (1)

Software diagnosis

EXPERIMENTAL

Software diagnosis with gold standard of echocardiography.

Device: "Chang Gung" Ventricular Systolic Dysfunction Screening Software

Interventions

"Chang Gung" Ventricular Systolic Dysfunction Screening Software DEVICE

This software is suitable for 12-lead ECG signals of adults over 20 years old, and assists doctors in screening patients for left ventricular systolic dysfunction.

Software diagnosis

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Echocardiography data within 14 days before or after the electrocardiogram acquisition time.
• The electrocardiogram signal is 500 Hz.
• The Alternating current (AC) filter of the electrocardiogram signal is 60 Hz.
• The length of the electrocardiogram signal is ten seconds (the electrocardiogram output of model MAC5500 is ten seconds, and there is no need to capture a segment).

You may not qualify if:

• Cases used in the model development process.
• Lacks any electrode.
• Contain any electrode lacks a segment.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung memorial hospital

Taoyuan, 333, Taiwan

Location

Related Publications (7)

• Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

  PMID: 28785469 BACKGROUND

• Kannel WB, Ho K, Thom T. Changing epidemiological features of cardiac failure. Br Heart J. 1994 Aug;72(2 Suppl):S3-9. doi: 10.1136/hrt.72.2_suppl.s3. No abstract available.

  PMID: 7946754 BACKGROUND

• Attia ZI, Kapa S, Lopez-Jimenez F, McKie PM, Ladewig DJ, Satam G, Pellikka PA, Enriquez-Sarano M, Noseworthy PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Friedman PA. Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Nat Med. 2019 Jan;25(1):70-74. doi: 10.1038/s41591-018-0240-2. Epub 2019 Jan 7.

  PMID: 30617318 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available.

  PMID: 28455343 BACKGROUND

• Bozkurt B, Hershberger RE, Butler J, Grady KL, Heidenreich PA, Isler ML, Kirklin JK, Weintraub WS. 2021 ACC/AHA Key Data Elements and Definitions for Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Heart Failure). J Am Coll Cardiol. 2021 Apr 27;77(16):2053-2150. doi: 10.1016/j.jacc.2020.11.012. Epub 2020 Nov 26. No abstract available.

  PMID: 33250265 BACKGROUND

• Taylor CJ, Ordonez-Mena JM, Roalfe AK, Lay-Flurrie S, Jones NR, Marshall T, Hobbs FDR. Trends in survival after a diagnosis of heart failure in the United Kingdom 2000-2017: population based cohort study. BMJ. 2019 Feb 13;364:l223. doi: 10.1136/bmj.l223.

  PMID: 30760447 BACKGROUND

• Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

  PMID: 30700139 BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Chang-Fu Kuo, MD/Ph.D

  Associate Professor and Director Division of Rheumatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators collected retrospective data and gave to the software to interpret. Echocardiography as the gold standard, and tested whether the software could correctly interpret left ventricular systolic dysfunction.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 16, 2023
• Study Start: April 15, 2023
• Primary Completion: August 15, 2023
• Study Completion: October 2, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)