Ospedale Galeazzi-Sant'Ambrogio
Milan, Lombardy, 20157, Italy
Location status: Recruiting
NCT Number: NCT06285084
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
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Milan, Lombardy, 20157, Italy
Location status: Recruiting
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.
The DL model requires training to be calibrated. The project plans to conduct accuracy evaluations on the validation population (76 athletes) and training trials on a different dataset (455 athletes).
There will be an initial phase of system training. Athletes will be assessed according to current guidelines and the italian cardiological guidelines for competitive sports participation - COCIS, with the required diagnostic tests on a case-by-case basis. At the end of the cardiac evaluation, athletes can be classified as "fit" or "unfit" for competitive activity.
Participants will submit the ECGs of "fit" and "unfit" athletes, categorized into these two groups, to a deep learning algorithm to train the artificial intelligence system.
A population of consecutive athletes will then be recruited to form the validation set for the test. These athletes have indications for evaluation for the granting of competitive fitness, as indicated by the referring sports physicians. In this case as well, athletes in the validation set will be assessed according to guidelines and COCIS with appropriate tests on a case-by-case basis to evaluate fitness for competition.
Participants will subject the ECGs of the validation set athletes to the artificial intelligence model to assess accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and AUC in discriminating athletes judged "fit" from those judged "unfit" for competitive activity after cardiac investigations.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From first medical evaluation with ECG until the final medical decision on competitive sports eligibility, up to 12 months
The accuracy of the DL model in recognizing the ECGs of athletes deemed fit or unfit will be evaluated by comparing the results with those obtained from the assessment performed by the sports physician (gold standard).
Participants will categorize the athletes into true positives, false positives, true negatives, and false negatives.
To define the ability of the DL model to discriminate between ECGs of athletes deemed fit or unfit, the receiver operating characteristic (ROC) curve and the corresponding area under the curve (AUC) will be calculated.
Contact information is provided by the study sponsor or research team.
Daniele Andreini, MD, PhD
CONTACT
Davide Marchetti, MD
CONTACT
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Other
Acronym: VALETUDO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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