Clinical Validation of PROPECG-TMT

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).

Completed

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Biomedicine Systems Informatics, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

TMT ECG exams adjudicated as equivocal cases

Exclusion criteria

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

Treatment and study plan

Screening for coronary artery revascularization based on TMT-ECG

Other

Screening for coronary artery revascularization based on TMT-ECG with and without the assistance of PROPECG-TMT

Primary outcomes

measurement of screening performances

Time frame: 1 month

calculation of sensitivity, specificity, NPV, PPV

Secondary outcomes

Time needed for screening all cases

Time frame: 1 month

measurement of the time and comparison between the two cohorts

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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.

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 3, 2024
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed