Actively Recruiting
Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2024-02-29
531
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of a Deep Learning (DL) model to analyze electrocardiogram (ECG) traces from athletes to provide a probability-based assessment of cardiovascular disease risk. This observational study aims to develop and validate this model to help determine athletes' eligibility for competitive sports. The study follows current guidelines and cardiological standards for evaluating athletes' heart health. The study involves two groups of athletes. The first group of 455 athletes has already undergone standard clinical evaluations for sports participation clearance; their ECGs and clinical results will be used to train the DL model. The second group of 76 athletes will be evaluated using standard fitness tests and the DL model to validate its accuracy. Participants in both groups are classified as "fit" or "unfit" for competitive sports based on medical assessments. Participants will undergo ECG tests and clinical evaluations according to established cardiological guidelines. Researchers will collect and analyze ECG data to train and test the DL model, measuring its accuracy, sensitivity, and specificity in classifying athletes' fitness for competition. The study duration for each participant can last up to 12 months from the first medical evaluation to the final decision on sports eligibility.
CONDITIONS
Brief Title
Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Athletes needing cardiac or sports medical evaluation for competitive eligibility
- Participation in sports like soccer or with mixed or aerobic cardiovascular demands as per COCIS 2017
- Age between 18 and 60 years
- No history of cardiovascular disease
- Signed informed consent
You will not qualify if you...
- Athletes involved in skill-based sports according to COCIS 2017
- High clinical probability of cardiovascular disease such as typical angina or heart failure
- Pregnancy or breastfeeding (self-declared)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo cardiac evaluations according to current guidelines and the Italian cardiological guidelines (COCIS) with diagnostic tests on a case-by-case basis to determine fitness for competitive sports.
Visits as needed depending on clinical evaluation
Duration - Up to 12 months
Participants' ECGs are submitted to the deep learning algorithm to assess the accuracy of the model in classifying athletes as fit or unfit for competitive activity.
Monitoring during the evaluation period
Trial Site Locations
Total: 1 location
1
Ospedale Galeazzi-Sant'Ambrogio
Milan, Lombardy, Italy, 20157
Actively Recruiting
Research Team
D
Davide Marchetti, MD
D
Daniele Andreini, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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