Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer (REDEEM-CAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 748
- 试验地点
- 2
- 主要终点
- Proportion of evaluated patients who should undergo CAD prevention
研究概览
简要总结
REDEEM-CAD is a prospective multi-centre study of CAD risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy >5 years ago.
详细描述
REDEEM-CAD is a prospective multi-centre study in which a process of evaluating the risk of coronary artery disease is studied in cancer survivors 40-70 years with chemotherapy or radiotherapy >5 years ago. The efficacy of this CAD risk evaluation will be compared with the broad community in two existing studies - CAUGHT-CAD and EDCAD. This unique Screening/Management Plan (SMP) has 2 components; 1) A novel clinical and imaging-based screening algorithm to select those most likely to develop coronary artery disease, 2) A clinical review to ensure optimal risk factor control and cardio protection.
Follow-up of treated patients will continue for an average of 36 months, with clinic reviews at 12, 24 and 36 months. The results will define the prevalence of subclinical coronary artery disease, and the feasibility and the efficacy of the SMP.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A history of cancer >5 y ago associated with potential cardiotoxicity from chemotherapy and/or radiotherapy (chiefly survivors of breast cancer, Hodgkin's lymphoma and prostate cancer).
排除标准
- •Unable to provide written informed consent to participate in this study
- •Known coronary artery disease at recruitment
- •History of previous coronary artery disease
- •Inability to acquire interpretable CT images
- •Contraindications/Intolerance to or already taking statin therapy
- •Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
结局指标
主要结局
Proportion of evaluated patients who should undergo CAD prevention
时间窗: 3 years
High clinical risk, or intermediate risk with CAC score \>0
次要结局
- Proportion with critical CAD(3 years)
- Statin responsiveness(3 year follow-up)
- Proportion at intermediate clinical risk(3 years)