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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07534384). StuddyBuddy aggregates publicly available trial information.