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临床试验/NCT06939205
NCT06939205已完成不适用

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

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
主要终点
Body surface area (BSA)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy subjects
  • •regular sports participation

排除标准

  • •athletic heart syndrome

结局指标

主要结局

Body surface area (BSA)

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Alessandro Minetto

Full Professor

University of Turin, Italy

研究点 (1)

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