The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
NCT Number: NCT07230327
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
And diagnosed with non-radiographic or radiographic axial SpA
These studies will be performed on a 3Tesla (T) MR system (Achieva, Philips Medical Systems) for all patients.
Time frame: 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.
Time frame: Five yeas
To elucidate the correlation between WB-MRI changes and inflammation, structural damage and disease activity in patients with axSpA.
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital with Nanjing Medical University
Other
Research on a New Disease Activity Assessment System for axSpA Based on Whole-body Magnetic Resonance Imaging Cohort
Acronym: NJSpAM
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