Clinical Trial

Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility

Study acronym: VALETUDO
Recruiting
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Record status
This record was last updated February 29, 2024 (before its estimated November 2, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observationl study is to evaluate the possibility of building a Deep Learning (DL) model capable of analyzing electrocardiographic traces of athletes and providing information in the form of a probability stratification of cardiovascular disease. Researchers will enroll a training cohort of 455 participants, evaluated following standard clinical practice for eligibility in competitive sports. The response of the clinical evaluation and ECG traces will be recorded to build a DL model. Researchers will subsequently enroll a validation cohort of 76 participants. ECG traces will be analyzed to evaluate the accuracy of the model to discriminate participants cleared for sports eligibility versus participants who need further medical tests
Trial Details
NCT Number NCT06285084
Lead Sponsor I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions Sports Cardiology, Preventive Cardiology, Electrocardiogram, Artificial Intelligence
Enrollment 531 participants
Start Date 2024-02-02
Primary Completion 2025-11-02 (estimated)
Study Completion 2027-02-02 (estimated)
Updated on ClinicalTrials.gov 2024-02-29