Left Ventricular Systolic DysfunctionNCT05861115
A Study to Evaluate Accuracy and Validity of the "Chang Gung" Ventricular Systolic Dysfunction Screening Software
A study testing "Chang Gung" Ventricular Systolic Dysfunction Screening Software in people with Left Ventricular Systolic Dysfunction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Left Ventricular Systolic Dysfunction
- What is being tested?
- "Chang Gung" Ventricular Systolic Dysfunction Screening Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2023to 2 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Cases used in the model development process.
- Lacks any electrode.
- Contain any electrode lacks a segment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This is a retrospective study conducted in Taiwan that aimed to test the performance of "Chang Gung" Ventricular Systolic Dysfunction screening software using electrocardiogram (ECG) and echocardiography data. The study data was obtained from a database that includes six hospitals of Chang Gung Memorial Hospital, between January 1, 2006, and December 31, 2019.
The software was developed using a training set of 133,225 data and validated using a set of 57,134 data. For clinical validation, a total of 1,172 test data were randomly selected from the testing set, stratified by hospital classification, age group and gender. The hospital classification, age group and gender ratios were based on the proportion of the testing data. The test data were also stratified by the presence or absence of left ventricular systolic dysfunction(LVSD) for test group and control group, defined as a heart output rate of less than 40% within 14 days before and after the ECG recording.
During the clinical trial, a cardiologist with 15 years of experience in treating cardiovascular disease examined the ECG data without any exclusion criteria. The cardiologist also confirmed the accuracy of the left ventricular ejection fraction (LVEF) measurement, which was defined as LVSD in the echocardiography reports. The LVEF was extracted from legally-binding echocardiography reports, not by the cardiologist during the clinical trial. The ECG data were screened and filtered for quality before being input into the software. The primary outcome was the sensitivity of the software, which was defined as not inferior to 0.86. The study also analyzed secondary outcome measures, including the area under the receiver operating characteristic curve, accuracy, specificity, positive predictive value, negative predictive value, false-positive rate, and false-negative rate.
- Conditions
- Left Ventricular Systolic Dysfunction
- Being tested
- "Chang Gung" Ventricular Systolic Dysfunction Screening Software
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Chang Gung" Ventricular Systolic Dysfunction Screening SoftwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Software diagnosis | Experimental | Software diagnosis with gold standard of echocardiography. Receives: Device: "Chang Gung" Ventricular Systolic Dysfunction Screening Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The rate of test results that correctly indicate the presence.
Measured: baseline
Secondary outcomes (7)
Specificity
The rate of test results that correctly indicate the absence.
Measured: Baseline
Accuracy
The rate of all test results that correctly indicated.
Measured: Baseline
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.
Measured: Baseline
Positive predictive value
The proportions of positive results in statistics and diagnostic tests that are true positive results
Measured: Baseline
Negative predictive value
The proportions of negative results in statistics and diagnostic tests that are true negative results
Measured: Baseline
False positive rate
The rate of test result which wrongly indicates that a particular condition or attribute is present
Measured: Baseline
False negative rate
The rate of test result which wrongly indicates that a particular condition or attribute is absent
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Apr 2023
- Primary completion15 Aug 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Systolic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang-Fu Kuo, MD/Ph.D, Study chair, Associate Professor and Director Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861115
- Sponsor's protocol ID
- 202200402B0C602
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28785469Kannel 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.
PubMed 7946754Attia 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.
PubMed 30617318Yancy 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.
PubMed 28455343Bozkurt 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.
PubMed 33250265Taylor 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.
PubMed 30760447Benjamin 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.
PubMed 30700139
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Accuracy and Validity of the "Chang Gung" Ventricular Systolic Dysfunction Screening Software
- ClinicalTrials.gov ID
- NCT05861115
- Acronym / sponsor ID
- 202200402B0C602
- Conditions
- Left Ventricular Systolic Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,172 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective study conducted in Taiwan that aimed to test the performance of "Chang Gung" Ventricular Systolic Dysfunction screening software using electrocardiogram (ECG) and echocardiography data. The study data was obtained from a database that includes six hospitals of Chang Gung Memorial Hospital, between January 1, 2006, and December 31, 2019.
The software was developed using a training set of 133,225 data and validated using a set of 57,134 data. For clinical validation, a total of 1,172 test data were randomly selected from the testing set, stratified by hospital classification, age group and gender. The hospital classification, age group and gender ratios were based on the proportion of the testing data. The test data were also stratified by the presence or absence of left ventricular systolic dysfunction(LVSD) for test group and control group, defined as a heart output rate of less than 40% within 14 days before and after the ECG recording.
During the clinical trial, a cardiologist with 15 years of experience in treating cardiovascular disease examined the ECG data without any exclusion criteria. The cardiologist also confirmed the accuracy of the left ventricular ejection fraction (LVEF) measurement, which was defined as LVSD in the echocardiography reports. The LVEF was extracted from legally-binding echocardiography reports, not by the cardiologist during the clinical trial. The ECG data were screened and filtered for quality before being input into the software. The primary outcome was the sensitivity of the software, which was defined as not inferior to 0.86. The study also analyzed secondary outcome measures, including the area under the receiver operating characteristic curve, accuracy, specificity, positive predictive value, negative predictive value, false-positive rate, and false-negative rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Software diagnosis | Experimental | Device: "Chang Gung" Ventricular Systolic Dysfunction Screening SoftwareSoftware diagnosis with gold standard of echocardiography. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Cases used in the model development process.
- Lacks any electrode.
- Contain any electrode lacks a segment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Chang Gung" Ventricular Systolic Dysfunction Screening SoftwareThis 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. | Device | Software diagnosis |
Primary outcome
Sensitivity
Time frame: baseline
The rate of test results that correctly indicate the presence.
7 secondary outcomes
Specificity
Time frame: Baseline
Accuracy
Time frame: Baseline
Area Under the receiver operating characteristic Curve
Time frame: Baseline
Positive predictive value
Time frame: Baseline
Negative predictive value
Time frame: Baseline
False positive rate
Time frame: Baseline
False negative rate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 28785469Savarese 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.
- Background: PubMed 7946754Kannel 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.
- Background: PubMed 30617318Attia 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.
- Background: PubMed 28455343Yancy 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.
- Background: PubMed 33250265Bozkurt 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.
- Background: PubMed 30760447Taylor 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.
- Background: PubMed 30700139Benjamin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Fu Kuo, MD/Ph.D study chair
Associate Professor and Director Division of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Chang Gung" Ventricular Systolic Dysfunction Screening Software in people with Left Ventricular Systolic Dysfunction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861115, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.