Clinical Validation of PROPECG-TMT

NCT06624852 | Completed

• 1 other identifier: 4-2023-0086
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• measurement of screening performances

  calculation of sensitivity, specificity, NPV, PPV

  1 month

Secondary Outcomes (1)

• Time needed for screening all cases

  1 month

Study Arms (2)

Performances with AI assistance

Performances of screening coronary artery revascularization with PROPECG-TMT

Other: Screening for coronary artery revascularization based on TMT-ECG

Performances without AI assistance

Performances of screening coronary artery revascularization without PROPECG-TMT

Other: Screening for coronary artery revascularization based on TMT-ECG

Interventions

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

Performances with AI assistance; Performances without AI assistance

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• TMT ECG exams adjudicated as equivocal cases

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Biomedicine Systems Informatics, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: February 13, 2023
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)