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Cardiovascular Pre-participation Screening in Children and Adolescents

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sports participation is strongly encouraged in children and adolescents, but intense training at early ages may reveal hidden heart conditions that increase the risk of sudden cardiac death. Pre-participation evaluation aims to identify these conditions before sports practice. This observational study will evaluate children and adolescents enrolled in the São Paulo Olympic Program (Programa São Paulo Olímpico). All participants will undergo a structured medical interview, a standardized physical examination and a resting 12-lead electrocardiogram (ECG). Participants with borderline ECG findings, warning symptoms, abnormal physical examination findings or a suggestive personal or family history will also undergo a 3-minute step test (Harvard step test) with continuous ECG recording during exercise and recovery, in order to detect exercise-induced arrhythmias. The main goal is to estimate the prevalence of potentially pathological ECG findings in this population. The study will also describe warning signs in the medical history, abnormal physical examination findings, step test results, and the referrals and confirmed diagnoses during follow-up.
Trial Details
NCT Number NCT07862504
Lead Sponsor University of Sao Paulo
Conditions Sudden Cardiac Death, Cardiac Arrhythmias
Enrollment 334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov