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Clinical Trials/NCT06939205
NCT06939205CompletedNot Applicable

The Impact of Different Body Surface Area Prediction Equations on Ventricular Dilatation Prevalence in Youth Soccer Players

University of Turin, Italy1 site in 1 country400 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Body surface area (BSA)

Study Overview

Brief Summary

The goals of this observational study are to investigate the accuracy of different predictive equations for body surface area (BSA) estimation and to evaluate the impact of different BSA normalizations on ventricular dilatation prevalence in youth soccer players. Two convenience samples of young soccer players of both genders will be recruited. Acquisition of optical images (for the players of the first sample), two-dimensional echocardiographic assessment (for the players of the second sample), and weight and height measurements (for the players of both samples) will be performed. BSA estimates will be derived from optical images (for the players of the first sample) and from ten different predictive equations obtained from the literature (for the players of both samples). Comparisons between optical imaging - derived BSA and BSA estimates obtained with the ten predictive equations will be performed for the players of the first sample. Absolute and relative values of different echocardiographic variables will be considered for the players of the second sample to assess the ventricular dilatation prevalence.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
12 Years to 30 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •healthy subjects
  • •regular sports participation

Exclusion Criteria

  • •athletic heart syndrome

Outcomes

Primary Outcomes

Body surface area (BSA)

Time Frame: Baseline (preseason investigation)

Estimation of the BSA value: weight (unit of measurement: kg) and height (unit of measurement: m) will be combined to report BSA in m\^2

Left ventricular dilatation prevalence

Time Frame: Baseline (preseason investigation)

Absolute and relative (normalized to body surface area - BSA) values of the following echocardiographic variables will be considered: 1) left ventricular end-diastolic diameter (LVEDD: absolute value in mm; relative value in mm/m\^2); 2) left ventricular end diastolic volume (LVEDV: absolute value in ml; relative value in ml/m\^2). The left ventricular dilatation will be identified if one or both the relative variables are above the following cut-points: i) LVEDD: 30 mm/m\^2 for males and 31 mm/m\^2 for females; ii) LVEDV: 74 ml/m\^2 for males and 61 ml/m\^2 for females.

Right ventricular dilatation prevalence

Time Frame: Baseline (preseason investigation)

Absolute and relative (normalized to body surface area - BSA) values of the fright ventricular basal diameter (RVBD: absolute value in mm; relative value in mm/m\^2) will be considered. The right ventricular dilatation will be identified if RVBD is above the cut-point of 22 mm/m\^2 for both males and females

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Turin, Italy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marco Alessandro Minetto

Full Professor

University of Turin, Italy

Study Sites (1)

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