BudapestICIVasc: Cardiovascular side effects of immune checkpoint inhibitor oncological therapies and their monitoring in the context of onco-cardiology
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The primary endpoint is defined as a 5-point MACE composite endpoint, which includes the following events: • cardiovascular death, • non-fatal myocardial infarction, • non-fatal stroke, • unstable angina requiring hospitalization and/or urgent coronary revascularization, • hospitalization due to heart failure.
研究概览
简要总结
In this study, we aim to investigate the cardiovascular side effects of immune checkpoint inhibitors.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients presented to the oncology teams of Semmelweis University and clinics in the country wishing to join the research
- •Planned immune checkpoint inhibitor therapy
- •At least 18 years of age
- •Signing of the patient information sheet and consent form by the patient
- •Accessible medical history
排除标准
- •Lack of informed consent form
- •Age under 18
- •Pregnancy and breastfeeding
结局指标
主要结局
The primary endpoint is defined as a 5-point MACE composite endpoint, which includes the following events: • cardiovascular death, • non-fatal myocardial infarction, • non-fatal stroke, • unstable angina requiring hospitalization and/or urgent coronary revascularization, • hospitalization due to heart failure.
The primary endpoint is defined as a 5-point MACE composite endpoint, which includes the following events: • cardiovascular death, • non-fatal myocardial infarction, • non-fatal stroke, • unstable angina requiring hospitalization and/or urgent coronary revascularization, • hospitalization due to heart failure.
次要结局
- For a detailed assessment of the cardiovascular safety of the treatment, the following events will be analyzed as secondary endpoints: • newly developing or worsening arterial hypertension; • cardiac arrhythmias; • venous thromboembolic events; • other clinically relevant cardiovascular adverse events; • hospitalization for cardiac reasons, if not part of the MACE composite event defined as the primary endpoint
研究者
Semmelweis University Heart and Vascular Centre
Scientific
Semmelweis University