Automated CPET Interpretation: International Validation Study

International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing

The goal of this observational experimental study is to validate a rule-based algorithm to automate CPET interpretation.

The endpoints of this study are the following:

• The change in agreement between key opinion leaders (KOLs) and the algorithm-generated CPET interpretation reports, comparing baseline to the end of the 6 month study period.
• Baseline agreement between KOLs and the algorithm
• Agreement at 6 months between KOLs and the algorithm
• Change in self-reported confidence scores before and after using the automated report
• Feedback on automated protocols generated via the platform during the 6-month implementation period
• Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints

Patients referred for a CPET will be included to collect observational data without interference within clinical routine. KOLs will be recruited from participating centres to fill out a survey for CPET interpretations.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiopulmonary Exercise Test

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Marieke Wuyts; Phone Number: 016 34 31 59; Email: marieke.wuyts@kuleuven.be

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • AZORG
    • Contact: Dimitri Stylemans; Phone Number: 0032 53 72 42 89; Email: dimitri.stylemans@azorg.be
    • Principal Investigator: Dimitri Stylemans
  • Leuven, Belgium, 3000
    • UZ Leuven
    • Principal Investigator: Wim Janssens
    • Contact: Marieke Wuyts; Phone Number: 016 34 31 59; Email: marieke.wuyts@kuleuven.be

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for a CPET in one of the participating centers

Description

Patients referred for a cardiopulmonary exercise test (CPET):

Inclusion Criteria:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form
• Patients referred for a CPET during their standard clinical care

Exclusion Criteria:

- If the participant has a disorder making it unable to perform a CPET, they must not proceed to be enrolled in the study and will be documented as a screen failure via applicable log forms in the Investigator Site File.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey	Change in agreement between key KOLs and the algorithm-generated CPET interpretation reports on the survey, comparing baseline (prior to implementation) to the 6-month study period. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs.	between baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey	Baseline agreement on the survey between the KOLs and the CPET interpretation algorithm will be assessed. The survey assesses CPET interpretation both without and with access to the automated report. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs. This establishes the initial level of alignment before implementation and allows evaluation of the immediate effect of having access to the report.	Baseline
Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey	Agreement at 6 months on the survey between the KOLs and the CPET interpretation algorithm will be assessed. Again the survey assesses CPET interpretation both without and with access to the automated report. Agreement will be assessed per interpretation domain using percent agreement and Cohen's kappa, with comparisons made both at the individual KOL level and across all KOLs.	6 months
Changes in self-reported confidence scores before and after the automated report	Change in self-reported confidence scores before and after using the automated report. Confidence will be rated on a 5-point Likert scale across interpretation domains. Within-timepoint comparisons (without vs. with algorithm) and across-time comparisons (baseline vs. 6 months) will be made.	At baseline, at 6 months, and the change between baseline and 6 months
Feedback on the automated protocols during the 6-month implementation period	Feedback on automated protocols generated via the platform during the 6-month implementation period. Changes will be categorised as: accept, accept with minor change, accept with major change or reject. This helps to quantify how the automated interpretation is accepted or refined in practice.	During the 6 months implementation period
Descriptive evaluation of center-level CPET interpretation practices	Descriptive evaluation of center-level CPET interpretation reports practices at three timepoints: at baseline, 3 months and 6 months on a random sample (n=10) of included participants of CPET interpretation reports per center, using structured qualitative coding of report content across interpretation domains to assess potential shifts in reporting style, terminology, and completeness.	Baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: AZORG
• Investigators: Principal Investigator: Wim Janssens, UZ/KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: CPET; automated interpretation
• Other Study ID Numbers: S70961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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