跳至主要内容
临床试验/NCT03885375
NCT03885375Unknown不适用

Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Progression of myocardial fibrosis and edema during follow-up period

研究概览

简要总结

Cardiac involvements in autoimmune diseases (AD) is common but underestimated and an early detection remains a clinical challenge for lacking of efficient imaging methods. The objective of the study was to investigate LV myocardial abnormalities in AD patients by multimodal cardiac imaging, including speckle-tracking echocardiology (STE), cardiac magnetic resonance imaging (CMRI) and positron emission tomography (PET).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease.
  • Patient is capable of complying with study procedures

排除标准

  • Patient is pregnant or nursing
  • Patient is complicated with congenital heart disease
  • Patient had cardiac surgery before
  • Patient is complicated with serious infections
  • Patient is complicated with organ failure
  • Patient is complicated with tumors
  • Patient is diagnosed indefinitely
  • Patient has been involved in other clinical trial

结局指标

主要结局

Progression of myocardial fibrosis and edema during follow-up period

时间窗: 1 year - 2 years

Late Gadolinium Enhanced, T1 mapping and T2 mapping tested by CMRI

Change in deformational parameters in echocardiography during follow-up period

时间窗: 6 months - 1 year - 2 years

global longitudinal strain (%), circumferential strain (%) and radial strain (%) measured by STE in autoimmune diseases

Change in myocardial perfusion during follow-up period

时间窗: 1 year - 2 years

SUVmax examined by PET

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 (1)

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