跳至主要内容
临床试验/NCT04443400
NCT04443400Unknown不适用

Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy

研究概览

简要总结

The purpose of this study is to detecte and predict early subclinical cardiac damage induced by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers.

详细描述

This is a monocentric prospective cohort study in which 100 patients treated for malignant tumors and with cardiac radiation exposure will be included.All patient will be followed for 12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers will be collected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • with malignant tumors
  • will receive radiotherapy
  • with cardiac exposure during the radiotherapy process
  • could receive regular follow-up for 12 months
  • written informed consent

排除标准

  • satisfactory echocardiographic images could not be obtained
  • moderate or severe valvular disease
  • cardiomyopathy
  • congenital heart disease
  • refractory hypertension
  • coronary artery disease*
  • heart failure
  • arrhythmia requiring intervention
  • pericarditis
  • acute myocarditis
  • participating in other clinical studies of drug intervention
  • severe liver and kidney dysfunction
  • autoimmune disease
  • pulmonary hypertension
  • coronary artery disease: at least 50% stenosis besed on previous coronary angiography or CTA, or with a history of percutaneous coronary stent implantation.
  • *: with LVEF<50%, unstable angina,or acute myocardial infarction within 3 months.

结局指标

主要结局

Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy

时间窗: 2020-2021

To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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