Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence

April 14, 2025 updated by: Marco Alessandro Minetto, University of Turin, Italy

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy
        • University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Soccer players of both genders

Description

Inclusion Criteria:

  • healthy subjects
  • regular sports participation

Exclusion Criteria:

- athletic heart syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (preseason investigation)
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.
Baseline (preseason investigation)
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
Baseline (preseason investigation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Marco Alessandro Minetto, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniTO&JMedBSAstudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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