T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
研究概览
简要总结
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
- •Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
- •Serum ferritin > 1,000
- •Written informed consent by the patient.
排除标准
- •Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
研究组 & 干预措施
1
Patients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction.
干预措施: T2* Cardiac and Liver MRI (Other)
结局指标
主要结局
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
时间窗: A single T2* MRI will be performed on eligible patients.
次要结局
- Evaluate left ventricular ejection fraction as assessed by T2* MRI.(A single T2* MRI will be performed on eligible patients.)
- Evaluate liver iron concentration as assessed by R2* MRI(A single T2* MRI will be performed on eligible patients.)