Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Cardiac T2* (MRI)
研究概览
简要总结
The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.
详细描述
The inevestigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.
The investigators will record concomitantly parameters which, according to literature data, may influence the occurrence of this complication, and will look for correlations with these parameters and iron overload (secondary objectives), in each of the 3 cohorts.
14 centres are involved and enrol patients with thalassemia, or sickle cell disease, or myelodysplasia having received in the past year > 8 erythrocyte concentrates, and having had a cardiac MRI. Patients files register the type of the disease, age at the beginning of transfusion and chelation, chelator type and dosage, liver and cardiac T2*.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thalassemia, sickle cell disease, myelodysplasia
- •having received in the past year > 8 erythrocyte concentrates
- •> 6 years of age
排除标准
- •preexisting cardiac disease
研究组 & 干预措施
thalassemia
patients affected with thalassemia
干预措施: Blood sample (Biological)
sickle cell disease
patients affected with sickle cell disease
干预措施: Blood sample (Biological)
myelodysplasia
patients affected with myelodysplasia
干预措施: Blood sample (Biological)
结局指标
主要结局
Cardiac T2* (MRI)
时间窗: Day 0
次要结局
- Liver T2*(MRI)(Day 0)