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临床试验/NCT04547465
NCT04547465Unknown不适用

The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors

Gia Dinh People Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab

研究概览

简要总结

The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks

详细描述

Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Breast cancer patients treated by anthracycline and/or trastuzumab
  • Have at least one of these cardiovascular risks: age > 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.

排除标准

  • Left ventricular ejection fraction < 50% before chemotherapy
  • Chronic heart failure with NYHA functional class >= II
  • Significant valvular stenosis/regurgitation
  • Acute heart failure due to acute coronary syndrome during follow-up

结局指标

主要结局

The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab

时间窗: two year follow-up

longitudinal strain (percentage)

The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab

时间窗: two year follow-up

global longitudinal strain (percentage)

The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk

时间窗: two year follow-up

the incidence

The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab

时间窗: two year follow-up

global longitudinal strain (percentage)

The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab

时间窗: two year follow-up

longitudinal strain (percentage)

次要结局

未报告次要终点

研究者

发起方
Gia Dinh People Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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