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NCT Number: NCT07534384

Automated CPET Interpretation: International Validation Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZORG, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Change in agreement between KOLs and algorithm-generated CPET interpretation report on the survey

    Time frame: between baseline and 6 months

    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.

Secondary outcomes

  1. Baseline agreement between KOLs and algorithm-generated CPET interpretation report on the survey

    Time frame: Baseline

    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.

  2. Agreement at 6 months between KOLs and the algorithm-generated CPET interpretation report on the survey

    Time frame: 6 months

    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.

  3. Changes in self-reported confidence scores before and after the automated report

    Time frame: At baseline, at 6 months, and the change between baseline and 6 months

    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.

  4. Feedback on the automated protocols during the 6-month implementation period

    Time frame: During the 6 months 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.

  5. Descriptive evaluation of center-level CPET interpretation practices

    Time frame: Baseline, 3 months and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marieke Wuyts

CONTACT

[email protected]

016 34 31 59

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • AZORG

Registry information

Official study title

International Validation Study of Automated Interpretation for Cardiopulmonary Exercise Testing

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

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.

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