A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
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
- 否
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
Wang Qiang
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
