Clinical Validation of PROPECG-TMT

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Screening for coronary artery revascularization based on TMT-ECG

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Biomedicine Systems Informatics, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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)

Description

Inclusion Criteria:

• TMT ECG exams adjudicated as equivocal cases

Exclusion Criteria:

• Exams not converting to median beat ECG
• Exams not containing interpretable exercise

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Performances with AI assistance; Performances of screening coronary artery revascularization with PROPECG-TMT	Other: Screening for coronary artery revascularization based on TMT-ECG; Screening for coronary artery revascularization based on TMT-ECG with and without the assistance of PROPECG-TMT
Performances without AI assistance; Performances of screening coronary artery revascularization without PROPECG-TMT	Other: Screening for coronary artery revascularization based on TMT-ECG; Screening for coronary artery revascularization based on TMT-ECG with and without the assistance of PROPECG-TMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of screening performances	calculation of sensitivity, specificity, NPV, PPV	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed for screening all cases	measurement of the time and comparison between the two cohorts	1 month

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 4-2023-0086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No