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NCT07534384
Automated CPET Interpretation: International Validation Study
Conditions: Cardiopulmonary Exercise Test
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 600
Sponsor: KU Leuven
Location: AZORG Aalst
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07534384). StuddyBuddy aggregates publicly available trial information.