NCT06285084 Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility
| NCT ID | NCT06285084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | Sports Cardiology |
| Study Type | OBSERVATIONAL |
| Enrollment | 531 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2025-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 531 participants in total. It began in 2024-02-02 with a primary completion date of 2025-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Athletes in need of cardiac or sports medical evaluation for the issuance of competitive eligibility. * Enlisted athletes involved in sports like soccer or those with mixed or aerobic cardiovascular demands according to the COCIS 2017 classification. * Aged 18 years or older but not exceeding 60 years. * No history of cardiovascular disease. * Signed Informed Consent. Exclusion Criteria: * Athletes engaging in skill-based sports as per the COCIS 2017 classification. * High clinical probability of cardiovascular disease, such as typical angina or heart failure. * Pregnancy and/or breastfeeding (confirmed through self-declaration).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06285084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Sports Cardiology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285084 currently recruiting?
Yes, NCT06285084 is actively recruiting participants. Contact the research team at davide.marchetti@grupposandonato.it for enrollment information.
Where is the NCT06285084 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06285084 clinical trial?
NCT06285084 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The trial plans to enroll 531 participants.