AI-Assisted Anaerobic Threshold Interpretation in Cardiopulmonary Exercise Testing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older.
Licensed physician or physician enrolled in a recognized postgraduate clinical training program at the study institution.
Eligible for one of the two prespecified seniority strata: senior physicians are attending physicians or above with at least 5 years of independent CPET interpretation experience; junior physicians are residents or specialty trainees with less than 5 years of independent CPET interpretation experience.
Able to interpret CPET examinations and use the study interface after standardized orientation.
Disqualifiers
Direct involvement in development, training, hyperparameter selection, or checkpoint selection of the PACE-Former model.
Prior access to the study case libraries, reference-standard annotations, or model outputs for the study examinations.
Unable to complete the required interpretation tasks or the 14 ± 3 day washout interval.
Withdrawal of consent before completion of study procedures.
Trial design
Design model
Crossover
Treatments tested in this trial
AI-Assisted Anaerobic Threshold Interpretation
Other interventionA 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.
Unassisted Cardiopulmonary Exercise Test Interpretation
Other interventionThe 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Difference in Absolute Anaerobic Threshold Localization Error
Absolute difference, in seconds, between the physician-selected AT time and the prespecified expert reference AT time. The primary estimand is the within-physician difference between AI-assisted and unassisted interpretations, analyzed across the same examinations using a crossed mixed-effects model.
Time frame
Recorded immediately after each case interpretation and analyzed after completion of both study periods, up to 2 monthsSecondary outcomes
1
Signed Anaerobic Threshold Localization Error
Signed difference, in seconds, between the physician-selected AT time and the prespecified expert reference AT time. Negative values indicate earlier placement and positive values indicate later placement relative to the reference.
Time frame
Recorded immediately after each case interpretation and analyzed after completion of both study periods, up to 2 months2
Proportion of Anaerobic Threshold Estimates Within 15 Seconds of the Reference
Proportion of interpretable examinations for which the physician-selected AT time is within 15 seconds, in either direction, of the prespecified expert reference AT time.
Time frame
Recorded immediately after each case interpretation and analyzed after completion of both study periods, up to 2 months3
Proportion of Anaerobic Threshold Estimates Within 30 Seconds of the Reference
Proportion of interpretable examinations for which the physician-selected AT time is within 30 seconds, in either direction, of the prespecified expert reference AT time.
Time frame
Recorded immediately after each case interpretation and analyzed after completion of both study periods, up to 2 months4
Agreement With the Reference Anaerobic Threshold Status
Agreement between the physician classification (AT confirmed, AT not reached, or unable to confirm) and the prespecified expert reference classification. Results will be summarized as overall agreement and condition-specific classification performance.
Time frame
Recorded immediately after each case interpretation and analyzed after completion of both study periods, up to 2 monthsSponsors and contacts
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Source ClinicalTrials.gov
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