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Automated CPET Interpretation: International Validation Study

StatusRecruiting
PhaseNot specified
SponsorKU Leuven
Started
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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Study sites: 2 to 3
    • Start date changed from estimate of Mar 30, 2026 to Mar 27, 2026
    • Secondary endpoints: details revised at 4 of 5 entries
    • Collaborators: 1 to 2
    • Eligibility criteria expanded, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
KU Leuven
69 trials monitored
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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.
Trial Details
NCT Number NCT07534384
Lead Sponsor KU Leuven
Collaborators: AZORG, Jessa Ziekenhuis Hasselt
Conditions
(from sponsor)		 Cardiopulmonary Exercise Test
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov