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临床试验/NCT02829580
NCT02829580已完成不适用

Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Evaluation of endothelial function

研究概览

简要总结

Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide.

The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Sickle cell group :
  • •Children with sickle cell syndrome (SS or SC)
  • •Children hospitalized in the hematology unit (day hospital)
  • •The girls set must have had a negative pregnancy test.
  • •One of the two holders of parental authority must have signed consent form
  • •Children affiliated to a social security scheme or equivalent
  • •Control group : Children recruited in a previous study :
  • •Holders of parental authority affiliated to a social security scheme
  • •Children recruited during the balance of a heart murmur or a vasovagal reaction
  • •Children whose cardiological examination is normal
  • •Children having no cardiovascular risk factor

排除标准

  • •Sickle cell group :
  • •Children with intercurrent diseases such as obesity, intra uterine growth retardation (IUGR), hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory
  • •Children who have sickle cell crisis there is less than 1 month.
  • •Control group :
  • •Children with intercurrent diseases: obesity, IUGR, hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory

研究组 & 干预措施

Sickle group

Experimental

Children with major sickle cell syndrome will have an usual Echocardiography

干预措施: Echocardiography (Procedure)

Control group

Active Comparator

Children recruited in a previous study and who had an usual Echocardiography

干预措施: Echocardiography (Procedure)

结局指标

主要结局

Evaluation of endothelial function

时间窗: baseline

Evaluation parameter of endothelial function (brachial artery): flow dependent dilatation (expressed in%)

次要结局

  • match the measurement systolic and diastolic diameters(baseline)
  • Match the measurement on the diastolic wall stress(baseline)
  • match the measurement thickness of the intima media(baseline)
  • distensibility cross sectional(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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