Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- LV systolic dysfunction
研究概览
简要总结
Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.
详细描述
The investigators will prospectively evaluate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR) and identify possibility of early detection of LV dysfunction in patients treated with trastuzumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HER2(+) breast cancer, anticipating Trastuzumab therapy
排除标准
- •Refusal to informed consent
- •Congenital heart disease
- •Significant arrhythmia in EKG
- •Regional wall motion abnormality (+) in echocardiography
- •Poor sonic window
结局指标
主要结局
LV systolic dysfunction
时间窗: 3-month F/U
LV systolic dysfunction was defined as following; 1. An EF unit drop of ≥10% from the baseline available echocardiogram or 2. Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram
次要结局
- LV systolic dysfunction(6,9, and 12-month F/U)
研究者
Hyung-Kwan Kim
MD, PhD, Assistant Professor, Seoul National University Cardiovascular center
Seoul National University Hospital