Coronary Artery DiseaseNCT06624852
Clinical Validation of PROPECG-TMT
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
This clinical validation evaluates the performances of physicians with and without learning with PROPECG-TMT assistance for screening coronary artery revascularization on TMT-ECG. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Screening for coronary artery revascularization based on TMT-ECG
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2023to 13 Feb 2024
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * At least 100 TMT ECG exams adjudicated as equivocal cases * 7% of exams are positive (one or more percutaneous coronary interventions or coronary artery bypass surgeries have been performed) and 93% of exams are negative (no percutaneous coronary interventions or coronary artery bypass surgery have been performed)
Who may be able to join
- TMT ECG exams adjudicated as equivocal cases
Who cannot join
- Exams not converting to median beat ECG
- Exams not containing interpretable exercise
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Biomedicine Systems Informatics, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: Clinical Validation of PROPECG-TMT: Evaluation of Ability of the Artificial Intelligence Model, PROPECG-TMT, to Improve Physician's in Screening Patients Who Needs Coronary Artery Revascularization Based on TMT-ECG.
This clinical validation evaluates the performances of physicians with and without learning with PROPECG-TMT assistance for screening coronary artery revascularization on TMT-ECG.
There are two endpoints used to evaluate performances: Accuracy (primary endpoints with pair specificity/sensitivity, and PPV/NPV), and time needed for screening (secondary endpoints with time measurements in all cases).
- Conditions
- Coronary Artery Disease
- Being tested
- Screening for coronary artery revascularization based on TMT-ECG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for coronary artery revascularization based on TMT-ECGOther
Screening for coronary artery revascularization based on TMT-ECG with and without the assistance of PROPECG-TMT
| Study group | Role | What they receive |
|---|---|---|
| Performances with AI assistance | Performances of screening coronary artery revascularization with PROPECG-TMT Receives: Other: Screening for coronary artery revascularization based on TMT-ECG | |
| Performances without AI assistance | Performances of screening coronary artery revascularization without PROPECG-TMT Receives: Other: Screening for coronary artery revascularization based on TMT-ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of screening performances
calculation of sensitivity, specificity, NPV, PPV
Measured: 1 month
Secondary outcomes (1)
Time needed for screening all cases
measurement of the time and comparison between the two cohorts
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start13 Feb 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624852
- Sponsor's protocol ID
- 4-2023-0086
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of PROPECG-TMT: Evaluation of Ability of the Artificial Intelligence Model, PROPECG-TMT, to Improve Physician's in Screening Patients Who Needs Coronary Artery Revascularization Based on TMT-ECG.
- ClinicalTrials.gov ID
- NCT06624852
- Acronym / sponsor ID
- 4-2023-0086
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 3 Oct 2024 (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.
This clinical validation evaluates the performances of physicians with and without learning with PROPECG-TMT assistance for screening coronary artery revascularization on TMT-ECG.
There are two endpoints used to evaluate performances: Accuracy (primary endpoints with pair specificity/sensitivity, and PPV/NPV), and time needed for screening (secondary endpoints with time measurements in all cases).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performances with AI assistance | – | Other: Screening for coronary artery revascularization based on TMT-ECGPerformances of screening coronary artery revascularization with PROPECG-TMT |
| Performances without AI assistance | – | Other: Screening for coronary artery revascularization based on TMT-ECGPerformances of screening coronary artery revascularization without PROPECG-TMT |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * At least 100 TMT ECG exams adjudicated as equivocal cases * 7% of exams are positive (one or more percutaneous coronary interventions or coronary artery bypass surgeries have been performed) and 93% of exams are negative (no percutaneous coronary interventions or coronary artery bypass surgery have been performed)
Key inclusion criteria (1 listed)
- TMT ECG exams adjudicated as equivocal cases
Key exclusion criteria (2 listed)
- Exams not converting to median beat ECG
- Exams not containing interpretable exercise
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 |
|---|---|---|
| Screening for coronary artery revascularization based on TMT-ECGScreening for coronary artery revascularization based on TMT-ECG with and without the assistance of PROPECG-TMT | Other | Performances with AI assistance, Performances without AI assistance |
Primary outcome
measurement of screening performances
Time frame: 1 month
calculation of sensitivity, specificity, NPV, PPV
1 secondary outcome
Time needed for screening all cases
Time frame: 1 month
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 3 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 2 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 3 Oct 2024. 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 South Korea. 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?
measurement of screening performances (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.