Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major cardiovascular event
研究概览
简要总结
Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer.
However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies.
The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.
详细描述
Retrospective two-center study comparing two groups of patients on immune checkpoint inhibitors:
- Group 1: active surveillance by serial troponin measures not prompted by cardiovascular symptoms ;
- Group 2: no troponin measures.
For any solid cancer or stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •All solid cancer patients treated by immune checkpoint inhibitors 2017-2022
排除标准
- •Patients enrolled in an invterventional study (e.g., pharma trial)
结局指标
主要结局
Major cardiovascular event
时间窗: 5 years
Acute coronary syndrome, stroke, myocarditis, heart failure, sustained ventricular arrhymias, cardiovascular death
次要结局
- Completion of cancer therapy as scheduled(5 years)