跳至主要内容
临床试验/NCT05593068
NCT05593068尚未招募不适用

Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic

Ramsay Générale de Santé1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
185
试验地点
1
主要终点
Presence of pancreatic iron deposit

研究概览

简要总结

Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.

In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male, female, over 18 years old
  • Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
  • Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
  • Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study

排除标准

  • Patient who has signed a form to object to the use of their health data
  • Pregnant woman
  • Poor adherence to the dialytic technique
  • Severe cognitive impairment
  • Hepatic cirrhosis
  • Frank inflammatory syndrome or an active infectious disease
  • Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases
  • Recent major bleeding (< 3 months)
  • Recent major surgery (< 3 months)
  • Transfusion dependence
  • Progressive malignant disease
  • Pacemakers incompatible with an MRI and metal heart valves

结局指标

主要结局

Presence of pancreatic iron deposit

时间窗: 1 day

Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2\* value in ms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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