Research on a New Disease Activity Assessment System for axSpA Based on Whole-body Magnetic Resonance Imaging Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- WB-MRI imaging characteristics of patients with axSpA.
研究概览
简要总结
This study aims to further improve and expand the WB-MRI imaging evaluation cohort of axSpA patients to complete dynamic follow-up and condition assessment. Based on the WB-MRI features, the association of WB-MRI signs with disease activity, inflammation, and structural damage will be analyzed. At the same time, in-depth data mining was conducted and machine learning was used to construct a new axSpA disease activity assessment model based on WB-MRI data, and the accuracy and reliability of the model were clearly evaluated in the discovery cohort and validation cohort.
详细描述
Axial spondyloarthritis (axSpA) is a common clinical chronic inflammatory joint disease with a high disability rate. Current assessment of axSpA disease activity mainly relies on patients' self-reported symptoms and signs, which has poor accuracy and reliability. At the same time, existing assessment methods fail to include some important disease characteristics of axSpA, such as active spinal inflammation and enthesitis. Therefore, there is an urgent need to establish a new axSpA disease activity assessment system.
With the development of imaging technology, whole-body MRI (WB-MRI) scanning technology is highly sensitive, can detect multiple parts at the same time, and can fuse multiple sequence images to make disease location and diagnosis more accurate. Currently, Much attention has been paid to it, but it has been less studied in axSpA.
This study established a disease activity assessment model based on WB-MRI imaging assessment, which will provide a new, effective and accurate method for axSpA disease assessment. At the same time, it will provide theoretical basis and practical basis for further understanding of the clinical characteristics of axSpA, the relationship between inflammation and structural damage.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Include newly referred patients if:
- •The onset of symptoms (back pain/arthritis/enthesitis) < 45 years
- •Undiagnosed disease with the following symptoms:
- •chronic back pain (duration of back pain more than 3 months) and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs) and/or enthesitis and/or dactylitis
排除标准
- •And diagnosed with non-radiographic or radiographic axial SpA
结局指标
主要结局
WB-MRI imaging characteristics of patients with axSpA.
时间窗: Two years
Compare the correlation between WB-MRI changes and disease activity, disease progression and structural damage at baseline and after 2 years of follow-up.
次要结局
- The correlation between WB-MRI changes and disease activities(Five yeas)
研究者
Wenfeng Tan
Clinical Professor
The First Affiliated Hospital with Nanjing Medical University