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临床试验/NL-OMON47646
NL-OMON47646已完成不适用

Cardiovascular Disease in Children with chronic inflammation - CDC study (cardiovascular disease in children)

niversitair Medisch Centrum Utrecht0 个研究点目标入组 116 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
12 至 64(—)

入选标准

  • General criteria for all groups:
  • * 12-19 years of age ;Obese adolescents:
  • Definition according to the international standards of the International Obesity Task Force, see Cole et al, BMJ, 2000. ;JIA adolescents:
  • * Polyarticular course JIA, including polyarticular JIA and extended oligoarticular JIA, rheumafactor negatieve. These patients often suffer from lifelong rheumatic disease, and are therefore at risk for early atherosclerosis.
  • * More than 1 year after diagnosis. In first year of disease, patients undergo multiple study procedures, causing a burden on patients. In order to reduce the general burden, this study will focus on patients after their first year of disease.
  • * BMI-SD < 2 (no obese children). ;Corrected aortic arch anomalies adolescents:
  • * Corrected aortic arch anomalies, i.e. hypoplastic aortic arch, coarctatio aortae, interrupted aortic arch. These patients are at risk for hypertension and early atherosclerosis.
  • * BMI-SD (standard deviation from BMI corrected for age and sex) < 2, to prevent including obese children in this group, to prevent obesity being a confounder in later analysis. ;Cystic fibrosis adolescents:
  • - Established cystic fibrosis, all mutations.
  • - BMI-SD < 2, to prevent inclusion of obese children so that obesity cannot be a confounder in later analysis. ;Corrected ASD adolescents:
  • * Corrected ASD.
  • * No other cardiac anomalies.
  • * BMI-SD < 2, to prevent inclusion of obese children so that obesity cannot be a confounder in later analysis.
  • NB. ASD correction < age 1 year has an excellent prognosis and is not associated with enhanced risk of early atherosclerosis.

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • * Intoxication (smoking, drug-use)
  • * Acute illness (fever)
  • * Mental retardation
  • * Claustrophobia
  • * A history of allergic reactions to MR contrast fluids
  • * Implanted electronic devices (i.e. pacemaker, internal cardioverter-defibrillator, cochlear implants, nerve- and bone stimulators)
  • * Subjects with ferromagnetic clips in brain, eyes or lungs
  • * A known reduced kidney function (GFR< 60 ml/min/1.73m2)
  • * Pregnancy
  • * Subjects who do not wish to be informed about abnormal findings of the cardiovascular MRI

研究者

发起方
niversitair Medisch Centrum Utrecht

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