Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)
- •Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)
- •Written informed consent
排除标准
- •Age > 70 years
- •Unable to perform anthracyline containing regimen
- •Previous treatment with mediastinal radiotherapy
- •Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)
- •ECOG PS > 2
- •Echocardiographic acoustic windows not suitable for strain evaluation
- •Any other conditions or situations preventing patients to sign informed consent
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)
Left ventricular ejection fraction measured by echocardiography
Global Longitudinal Strain (GLS)
时间窗: Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion)
Global Longitudinal Strain measured by strain-rate echocardiography
次要结局
- T troponin(Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion))
- Anthracycline cumulative dose(4/6 month after baseline (end of chemotherapy))
研究者
Mario Levis
Medical doctor
A.O.U. Città della Salute e della Scienza