Cardiovascular Pre-participation Screening in Children and Adolescents
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age under 18 years
Regular enrollment in organized sports in the São Paulo Olympic Program, with at least two training sessions per week
Informed consent signed by the legal guardian and assent signed by the participant
Availability to complete all study procedures (medical history, physical examination and resting electrocardiogram)
Disqualifiers
Inability to understand the study procedures
Refusal to participate by the legal guardian or the participant
Acute febrile illness in the 72 hours before data collection
Known structural heart disease under follow-up without medical clearance for sports practice
Trial population
Children and adolescents younger than 18 years regularly enrolled in organized sports in the São Paulo Olympic Program, with at least two training sessions per week, evaluated at the Heart Institute (InCor), São Paulo, Brazil.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pre-participation clinical evaluation
Other interventionStructured cardiovascular medical history and standardized physical examination.
Diagnostic Test: Resting 12-lead electrocardiogram
Diagnostic testResting 12-lead electrocardiogram (ECG) analyzed independently by two blinded sports cardiologists.
Diagnostic Test: Step test (Harvard step test)
Diagnostic test3-minute continuous step test with electrocardiogram (ECG) recording during exercise and recovery, performed only in participants with borderline ECG findings, warning symptoms, abnormal physical examination or suggestive personal or family history.
Treatment groups
334 Participants
are divided into 1 treatment groupGroup A: Young athletes3 interventions
Trial outcomes
Primary outcomes
1
Prevalence of potentially pathological findings on resting electrocardiogram
Proportion of participants whose resting 12-lead electrocardiogram (ECG) is classified as potentially pathological by two independent sports cardiologists blinded to clinical data, according to the study's operational classification
Time frame
At the pre-participation evaluation (day 1)Secondary outcomes
1
Prevalence of warning signs and symptoms in the medical history
Proportion of participants reporting cardiovascular warning symptoms or a relevant personal or family history in the structured questionnaire.
Time frame
At the pre-participation evaluation (day 1)2
Prevalence of abnormal physical examination findings
Proportion of participants with abnormal cardiovascular findings on standardized physical examination, including pathological murmurs, elevated blood pressure, abnormal pulses and Marfan phenotype.
Time frame
At the pre-participation evaluation (day 1)3
Factors associated with potentially pathological findings
Association between potentially pathological findings and age, sex, sport and training load, expressed as odds ratios from multivariable logistic regression.
Time frame
At the pre-participation evaluation (day 1)4
Prevalence of abnormal step test results
Proportion of participants undergoing the step test whose result is classified as borderline or abnormal (exercise-induced arrhythmias, significant ST-segment changes, dynamic T-wave inversion, prolonged corrected QT interval, high-grade atrioventricular block or symptoms during the test).
Time frame
Up to 30 days after the pre-participation evaluationSponsors and contacts
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Source ClinicalTrials.gov
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