Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-Dimensional Echocardiographic Speckle Tracking Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Changes in myocardial function - 2D-STE vs 3D-STE
研究概览
简要总结
This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To detect acute and subacute changes in myocardial function by two-dimensional (2D)-Speckle Tracking Echocardiography (STE) derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment.
Ia. To compare 2D-STE and three-dimensional (3D)-STE derived strain and strain-rate; Ib. To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction (LVEF); Ic. If feasible, to compare 2D-STE and cardiac biomarkers [serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)].
II. To predict chemotherapy-induced cardiotoxicity by using 2D-STE and/or other significant parameters for early detection of cardiac dysfunction.
OUTLINE: This is an observational study.
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 followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment
排除标准
- •First-line treatment not including doxorubicin
- •Treatment performed outside of Mayo Clinic with different protocols
- •Age < 18 years
结局指标
主要结局
Changes in myocardial function - 2D-STE vs 3D-STE
时间窗: Baseline, 3 months, 6 months, 1 year
Differences between two-dimensional speckle tracking echocardiography (2D-STE) and three-dimensional speckle tracking echocardiography (3D-STE) derived strain will be compared at baseline and over time.
Changes in myocardial function - 2D-STE
时间窗: Baseline, 3 months, 6 months, 1 year
Changes in myocardial function will be assessed using 2D-STE derived strain rate. Changes will be compared to baseline over time.
Changes in myocardial function - 2D-STE vs 2D-LVEF and 3D-LVEF
时间窗: Baseline, 3 months, 6 months, 1 year
Differences between 2D-STE and 2D- and 3D- left ventricle ejection fraction (2D-LVEF and 3D-LVEF, respectively) will be compared at baseline and over time.
Changes in myocardial function - 2D-STE vs cardiac biomarkers
时间窗: Baseline, 3 months, 6 months, 1 year
If feasible, 2D-STE and cardiac biomarkers \[serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)\] will be compared at baseline and over time.
次要结局
未报告次要终点