NCT02423356已完成不适用
The Ability of Strain Echocardiography to Predict Cardiotoxicity in Patients Receiving Standard Chemotherapy Regimens Containing Doxorubicin
Daniel Rushing2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Composite cardiotoxicity
研究概览
简要总结
The purpose of this study is to investigate the heart functioning of patients being treated with with doxorubicin chemotherapy who have sarcoma, lymphoma or breast cancer in order to better predict risk of developing symptomatic heart failure.
详细描述
Primary Objective:
- Determine if a 20% reduction in global longitudinal strain by echocardiography can predict subsequent composite cardiotoxicity in a collection of patients with either HER2(-) breast cancer, sarcoma, or lymphoma receiving modern chemotherapy regimens containing anthracyclines.
Secondary Objectives:
- Determine if a troponin I level of at least 0.08 ng/mL using high-sensitivity cardiac troponin I assay (Hs-cTn-I) can predict composite cardiotoxicity.
- Determine if a serum B-type natriuretic peptide (BNP) level of at least 200 pg/mL can predict composite cardiotoxicity.
- Determine independent predictors of cardiotoxicity among clinical parameters, serial echocardiography strain measurements, and biomarkers.
Exploratory Objectives:
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
- 否
入选标准
- •Patients must be at least 18 years old at the time of informed consent
- •Patients must be able to speak and read English.
- •Patients must be able to provide written informed consent and HIPAA authorization
- •Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer
- •Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
- •Patients must have planned treatment with doxorubicin:
- •Patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
- •Patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
- •Patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. Breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
- •NOTE: Patients can be on additional chemotherapeutic agents.
- •Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software.
排除标准
- •Clinical history of heart failure or ejection fraction (EF) on initial exam is <53%.
- •Initial echocardiograms are not interpretable.
- •Wall motion abnormalities are present on initial echocardiograms.
- •Strain on initial echocardiograms cannot be calculated.
结局指标
主要结局
Composite cardiotoxicity
时间窗: Up to 28 days prior to beginning chemotherapy, during chemotherapy (specifically, at the visit that will administer doxorubicin to a cumulative total of at least 225mg/m2), 6 months after starting chemotherapy, and 12 months after starting chemotherapy
Transthoracic echocardiograms with strain imaging
次要结局
- Serum cardiac biomarkers as predictors of composite cardiotoxicity(Up to 28 days prior to beginning chemotherapy, during chemotherapy (specifically, at the visit that will administer doxorubicin to a cumulative total of at least 225mg/m2), 6 months after starting chemotherapy, and 12 months after starting chemotherapy)
研究者
Daniel Rushing
Professor of Clinical Medicine
Indiana University School of Medicine
研究点 (2)
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