Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of patients with major cardiovascular advserse drug reactions
研究概览
简要总结
Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.
详细描述
Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for ~50% death rates.
Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry.
The aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up.
Mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects.
4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prescribed treatment by immune checkpoint inhibitors (ICI) for cancer
排除标准
- •previous treatment by any ICI
- •any contraindication to cardiac resonance magnetic imaging
- •contraindication to gadoteric acid, meglumin or any gadolinium-based contrast agent
- •pace maker or automated implantable defibrilator
- •pregnancy, breastfeeding
- •women of childbearing potential who do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion
- •patient under legal protection
- •renal failure defined by creatinine clearance <30ml/min/m² (CKD-EPI)
- •current participation or exclusion period of another interventional clinical study
- •Exclusion Criteria for ancillary studies:
- •hemoglobinemia < 9 g/dl
结局指标
主要结局
Number of patients with major cardiovascular advserse drug reactions
时间窗: 6 weeks
Incidence of a composite endpoint including myocarditis, pericarditis, acute coronary syndrome, acute heart failure, subclinial cardio-toxicity, high degree conduction abormalities or ventricular sustained arrythmias, cardiovascular death.
次要结局
- Number of patients with major cardiovascular advserse drug reactions(6 months)
- Number of patients with other cardiovascular advserse drug reactions(6 weeks and 6 months)
- Number of patients with isolated CMR abnormalities(6 weeks and 6 months)
- Number of patients with rhythm abnormalities that do not fullfill major advsere event criteria(6 weeks and 6 months)
- Risk factors for cardiovascular adverse drug event(6 weeks and 6 months)