NCT04046315Unknown不适用
Early Detection of Cardiac Damage With CMR in Women With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline
研究概览
简要总结
With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •A diagnosis of primary breast cancer
- •Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
- •Cardiotoxicity risk score of intermediate, high or very high risk
排除标准
- •Previous radiotherapy or systemic cancer treatment
- •Cancer metastasis
- •Life expectancy of less than 6 months
- •History of myocardial infarction or heart failure
- •Known contra-indications for CMR
- •Refusal or inability to provide informed consent
结局指标
主要结局
Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline
时间窗: Baseline and 2 weeks after the last chemotherapy cycle
A relative reduction in Global Longitudinal Strain (GLS) assessed with CMR
次要结局
未报告次要终点
研究者
研究点 (1)
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