Deep Learning ECG Evaluation and Clinical Assessment for Competitive Sport Eligibility (VALETUDO)

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

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Electrocardiogram; Sports Cardiology; Preventive Cardiology

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 531

Contacts and Locations

• Study Contact: Name: davide marchetti, MD; Phone Number: +390283506734; Email: davide.marchetti@grupposandonato.it
• Study Contact Backup: Name: Daniele Andreini, MD, PhD; Phone Number: +390283506734; Email: daniele.andreini@unimi.it

Study Locations

• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20157
      • Recruiting
      • Ospedale Galeazzi-Sant'Ambrogio
      • Contact: davide marchetti, MD; Phone Number: +390283506734; Email: davide.marchetti@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults requiring medical evaluation for competitive sports eligibility

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Training Cohort; 455 Athletes already evaluated for sports participation clearance, whom ECG and clinical evaluation (cleared - not cleared for competitive sports participation) will be fed into the DL model
Validation Cohort; 76 Athletes evaluated using standard sports eligibility clearance tests and our DL model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DL model accuracy	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.	From first medical evaluation with ECG until the final medical decision on competitive sports eligibility, up to 12 months

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): November 2, 2025
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VALETUDO Trial (L4195)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No