跳至主要内容
临床试验/NCT05982041
NCT05982041尚未招募不适用

A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

The First Affiliated Hospital with Nanjing Medical University0 个研究点目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations

研究概览

简要总结

Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.

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

入选标准

  • All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance imaging) or suspected clinically myositis
  • Age over 18 years old
  • Signature of the informed consent form for the study

排除标准

  • Patients with disease duration >2 years
  • Patients < 18 years
  • Confirmed non-inflammatory myopathies
  • Myositis secondary to alcohol or drug abuse
  • Patients unwilling or unable to give consent
  • Patients with poor or no venous access

结局指标

主要结局

The emergence of extra-cellular volume (ECV) > 30% in the different myositis subgroups based on radiological evaluations

时间窗: 20 years

On the basis of extra-cellular volume (ECV) \> 30% by CMR

The emergence of late gadolinium enhancement (LGE) positive in the different myositis subgroups based on radiological evaluations

时间窗: 20 years

On the basis of the late gadolinium enhancement (LGE) positive by CMR

次要结局

  • Number of participants with a significant change levels of diagnostic biomarkers(20 years)
  • Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls(20 years)
  • Incidence of major cardio-vascular events(20 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Qiang

The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital with Nanjing Medical University

相似试验

Adult Idiopathic Inflammatory Myopathy With Cardiac... | 临床试验