跳至主要内容
临床试验/NCT01665300
NCT01665300已完成不适用

Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年7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
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyung-Kwan Kim

MD, PhD, Assistant Professor, Seoul National University Cardiovascular center

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验