Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Non-calcified coronary plaque volume (difference between baseline and follow-up CT)
研究概览
简要总结
Immune checkpoint inhibitors (ICI) have revolutionized cancer treatment and are now approved for various types of cancer. The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body. Recently, concerns have also risen about cardiovascular effects of ICI. Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event.
The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke, are unclear. Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI, immune-related hypercoagulability or (autoimmune) antiphospholipid antibodies may play a role, but data to support this are lacking. The longer-term risk of arterial thromboembolism may be predominantly driven by (accelerated) atherosclerosis, a chronic low-grade inflammatory disease of the larger arteries. Therefore, this study evaluates the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography (CCTA).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma
- •Prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer)
- •Age ≥ 50 years
排除标准
- •ICI therapy in previous 12 months
- •Suspected or confirmed viral, fungal, or bacterial infectious disease
- •Use of immunosuppressive therapy prior to ICI start
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- •Known allergy to iodinated contrast agents
- •Atrial fibrillation
结局指标
主要结局
Non-calcified coronary plaque volume (difference between baseline and follow-up CT)
时间窗: 1 year
次要结局
- Plaque characteristics (differences between baseline and follow-up)(1 year)
- Differences in plasma biomarkers (pro-inflammatory markers) between baseline and follow-up(3 months, 1 year)
- Incidence of Arterial thromboembolic event(1 year, 5 years)
研究者
Hanneke W. M. van Laarhoven
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)