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临床试验/NCT00520559
NCT00520559已完成不适用

Incidence of Cardiac Complications in Patients With Cardiac Siderosis During 1 Year Follow-up and the Normal T2* Ranges in LVF, MI and Normal Population.

Imperial College London0 个研究点目标入组 652 人开始时间: 2007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
652
主要终点
Heart Failure

研究概览

简要总结

The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload.

详细描述

Key Definitions Myocardial siderosis - Iron deposition that occurs in the heart, usually in relation to recurrent blood transfusions and red cell breakdown.

Thalassaemia - A hereditary form of anaemia leading to recurrent blood transfusions and iron overload.

Cardiomyopathy - Disease of the heart leading to heart failure. In the case of cardiac siderosis it is entirely reversible.

Chelation - Drug used to remove iron from the heart T2* CMR - Cardiac Magnetic Resonance Imaging. A specialised scan that uses a large magnet to image the heart. As iron has magnetic properties we can use this scan to determine the amount of iron within the heart. T2* is a value that relates to the level of iron loading in the heart. A T2* of less than 10 relates to severe heart iron loading, a T2* of 10-20 relates to mild/moderate heart iron loading and a T2* of greater than 20 relates to no significant iron loading in the heart.

Heart failure - Disease in which the myocardium (heart muscle) weakens and can not pump blood efficiently. Fluid accumulates in the lungs, hands, ankles, or other parts of the body. The mortality from heart failure is very high.

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
18 Years 至 77 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thalassaemia Major
  • Patient must have had a cardiac MRI scan between 1999 and 2006

排除标准

  • Other structural heart disease such as valvular abnormalities, MI, congenital heart disease

结局指标

主要结局

Heart Failure

时间窗: 1yr

Ejection fraction

Arrhythmia

时间窗: 1yr

ECG

次要结局

未报告次要终点

研究者

申办方类型
Other

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