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临床试验/NCT04424095
NCT04424095Unknown不适用

Investigation of Chronic Venous Disease in Pediatric Population

University of Catanzaro1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Prevalence of Chronic Venous Disease

研究概览

简要总结

Chronic venous disease (CVD) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. CVD has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. The aim of this study is to assess the prevalence of CVD searching also for the early clinical and instrumental signs of this disease.

详细描述

Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population represents one of the main causes of morbidity in western countries, and it has also an important effect on healthcare cost absorbing 1-2% of the total health budget in western countries. Clinical manifestations related to CVD are well documented in adults, with clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a scarcity of published data regarding CVD in children, and in addition, venous duplex ultrasound test of the lower limbs is performed much less commonly in children than in adults.

Therefore, the natural history of pediatric venous reflux remains unclear, although it is possible that it precedes the onset of CVD in adulthood. In this context, this observational study aims to identify the presence of venous reflux, as well as clinical and morphological data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular visit and an echo duplex scan of lower limbs. The endpoints of this study are to prospectively assess the prevalence of CVD in children, as well as to evaluate a possible correlation between vein diameter and pathological vein reflux.

研究设计

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

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric Patients

排除标准

  • Patients with mental retardation
  • Patients with Marfan syndrome
  • Patients with an inability to stand or collaborate for the clinical tests.

结局指标

主要结局

Prevalence of Chronic Venous Disease

时间窗: at 9 month

The Prevalence of Chronic Venous Disease in the population study will be assessed.

Echo duplex evaluation

时间窗: at 10 month

The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population

次要结局

未报告次要终点

研究者

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

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

University of Catanzaro

研究点 (1)

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