Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence

NCT06939205 | Completed

• 1 other identifier: UniTO&JMedBSAstudy
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathies

Keywords

3-D optical imaging; Body surface area; soccer; transthoracic echocardiography

Outcome Measures

Primary Outcomes (3)

• Body surface area (BSA)

  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

  Baseline (preseason investigation)

• Left ventricular dilatation prevalence

  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.

  Baseline (preseason investigation)

• Right ventricular dilatation prevalence

  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

  Baseline (preseason investigation)

Interventions

Assessment of body surface area and assessment ventricular dilatation prevalence DIAGNOSTIC_TEST

Estimation of body surface area and quantification of absolute and relative values of echocardiographic variables

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Soccer players of both genders

You may qualify if:

• healthy subjects
• regular sports participation

You may not qualify if:

• \- athletic heart syndrome

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Torino, Italy

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marco Alessandro Minetto

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 22, 2025
• Study Start: December 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)