跳至主要内容
临床试验/NCT05125965
NCT05125965进行中(未招募)不适用

Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy

Centre Chirurgical Marie Lannelongue4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
4
主要终点
cardiac MRI

研究概览

简要总结

Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.

Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.

In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.

In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or other cardiovascular complications
  • Patient over 18 years of age
  • Patient affiliated to a health insurance plan
  • Patient who has given free, informed and oral consent

排除标准

  • Contraindication to immunotherapy
  • Pregnant or breastfeeding patient (if applicable)
  • Contraindication to cardiac MRI

研究组 & 干预措施

Patient undergoing immunotherapy with an indication for cardiac MRI

Experimental

Patient undergoing immunotherapy with an indication for cardiac MRI for suspected myocarditis or myocarditis or other cardiovascular complications

干预措施: additional time for the MRI (Other)

结局指标

主要结局

cardiac MRI

时间窗: 1 day

ejection fraction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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