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NOT YET RECRUITING
NCT07833137
NA

AI-Assisted Anaerobic Threshold Interpretation in Cardiopulmonary Exercise Testing

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

This prospective randomized two-period crossover reader study will evaluate whether assistance from a frozen artificial intelligence model improves physicians' interpretation of the anaerobic threshold (AT) in cardiopulmonary exercise testing (CPET). Sixteen physicians, including 8 senior and 8 junior readers, will each interpret 150 de-identified CPET examinations once without AI assistance and once with AI assistance. The primary outcome is the within-physician difference in absolute AT localization error between the assisted and unassisted conditions. Secondary outcomes include signed timing error, agreement on whether AT is present, estimates within 15 and 30 seconds of the reference, inter-reader reliability, interpretation time, and whether the effect of AI assistance differs by physician seniority.

Official title: A Randomized Two-Period Crossover Reader Study of Artificial Intelligence-Assisted Anaerobic Threshold Interpretation in Cardiopulmonary Exercise Testing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2026-09-25

Completion Date

2026-11-25

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

OTHER

AI-Assisted Anaerobic Threshold Interpretation

A frozen PACE-Former model provides a predicted anaerobic threshold time within the CPET review interface. Physicians retain responsibility for the final classification and AT time annotation. No other model output or reference label is displayed.

OTHER

Unassisted Cardiopulmonary Exercise Test Interpretation

The physician reviews the same de-identified CPET data using the study interface without display of any model prediction or AI-generated suggestion and independently classifies AT status and records the AT time when confirmed.

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China