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临床试验/NCT00629291
NCT00629291已完成不适用

Evaluation of Iron Overload in the Heart, Liver and Pancreas: Patients With Sickle β Thalassemia and Sickle Cell Anemia.

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
outcome measure: iron overload on T2* MRI in the heart , liver and pancreas.

研究概览

简要总结

Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.

详细描述

Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.

Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac MRI using T2* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test

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研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.

排除标准

  • contraindication to MRI

结局指标

主要结局

outcome measure: iron overload on T2* MRI in the heart , liver and pancreas.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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