Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Acute coronary syndrome
研究概览
简要总结
This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Histologically verified cancer
- •First-time treatment with 5-FU/Capecitabine
- •Expected remaining lifetime > 6 months
- •Informed consent
排除标准
- •Known ischemic heart disease
- •Ischemia-suspicious symptoms prior to 5-FU treatment
- •Ischemia-suspicious ECG-changes prior to 5-FU treatment
结局指标
主要结局
Acute coronary syndrome
时间窗: 6 months
Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome
次要结局
- Chest pain(6 months)