NCT04413487撤回不适用
Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in left ventricular ejection fraction (LVEF)
研究概览
简要总结
Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.
详细描述
- Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
- Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
- Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
- Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
- Patient records will be reviewed at 5 years to check cardiac status and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Males and females 18 years and above
- •Willing and able to provide consent
- •Able to read
- •Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
- •Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:
- •LVEF 50-54% by baseline echocardiogram
- •BMI ≥ 30 kg/m2
- •Current or prior anti-hypertensive therapy
- •Diagnosis of coronary artery disease (CAD)
- •Diabetes Mellitus
- •Atrial fibrillation/flutter
排除标准
- •Patients who are pregnant
- •Only single encounter without follow up
- •Cancer diagnosis other than breast or hematological cancer
- •Chemotherapy treatment other than anthracycline or trastuzumab
- •No prior chemotherapy treatment
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF)
时间窗: through study completion, an average of 1 year
a decrease in LVEF of ≥10 percentage points from baseline to a value of \< 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF \<50% for patients who have a baseline LVEF of 50-54%
次要结局
- Survival status(through study completion, an average of 1 year)
- Change in symptoms that may be indicative of heart failure(through study completion, an average of 1 year)
- Change in treatment that may be indicative of heart failure(through study completion, an average of 1 year)
- Change in strain echo that may be indicative of heart failure(through study completion, an average of 1 year)
研究者
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