Strain Imaging in Breast Cancer Patients Receiving Trastuzumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction
研究概览
简要总结
The purpose of this research study is to evaluate the effects of the chemotherapeutic drug, Trastuzumab (Herceptin) on the heart. Trastuzumab (Herceptin) is used to treat specific types of breast cancer and is known to cause weakening of the heart. Unfortunately, little is know as to why this this happens. The investigators want to identify any factors that may lead to the early detection, treatment and prevention of the cardiotoxicity (heart problem) associated with this drug.
详细描述
As a subject participating in this study the following information will be collected: complete past medical history including age, height, and weight will be done with each echocardiogram; blood pressure at clinic visits during treatment with trastuzumab, type of cancer will be noted, type of chemotherapy, doses of chemotherapy, type and dose of chemotherapy in the past, type and dose of radiation therapy received, names and doses of cardiac medications, results of cardiac tests, results of lab tests, family history of heart disease, and social history which will include risk factors for developing heart disease including tobacco and alcohol use. This information will be entered into a database for the investigators to try and detect any factors that may lead to the cardiotoxicity (heart problem) that may be caused by Trastuzumab (Herceptin).
Any transthoracic echocardiogram (heart ultrasound) ordered will be further evaluated for special parameters that may help to detect weakening of the heart earlier than a normal ultrasound. An echocardiogram (heart ultrasound) is when a probe is placed on the chest and pictures are taken using sound waves and a special camera.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age greater than 18 years
- •Her 2 positive breast cancer.
- •Patients who are currently receiving Trastuzumab (Herceptin).
- •Patients who received Trastuzumab (Herceptin) after the formation of the UFHealth Medical Plaza pharmacy database was initiated.
排除标准
- •Age less than 18 years
- •Patients who have not received Trastuzumab (Herceptin).
- •Patients who received Trastuzumab prior to the formation of the UFHealth Medical Plaza pharmacy database.
结局指标
主要结局
Left Ventricular Ejection Fraction
时间窗: Change in ejection fraction from baseline to end of study. Patients will be followed for a minimum of 1 year.
Left ventricular ejection fraction from all clinically indicated transthoracic echocardiograms will be compared from baseline through the end of the study.
Longitudinal Strain
时间窗: Change in baseline longitudinal strain from beginning of study to end of study. Patients will be followed for a minimum of 1 year.
Each transthoracic echocardiogram obtained during the patient's treatment will be assessed for longitudinal strain.
次要结局
- Cardiac medication use(Baseline to end of study. Patients will be follwed for a minimum of 1 year.)
- Clinically evident congestive heart failure(From baseline to end of study. Patients will be followed for a minimum of 1 year.)