RecruitingNCT06285084

Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility


Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

531 participants

Start Date

Feb 2, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This observational study aims to develop and validate an artificial intelligence (AI) model that can analyze electrocardiograms (ECGs) to identify which athletes may have hidden cardiovascular disease that would make competitive sports unsafe. By training the model on ECG data from athletes who have already undergone standard cardiac evaluation, researchers hope to create a tool that can quickly and accurately flag those who need further testing. Male and female athletes aged 18–60 who are seeking cardiac clearance for competitive sports and have no known cardiovascular disease history may be eligible. Participation involves undergoing standard sports cardiology evaluation and having your ECG submitted to the AI model — no additional testing beyond usual care is required. This summary was generated by AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Ospedale Galeazzi-Sant'Ambrogio

Milan, Lombardy, Italy

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NCT06285084


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