Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Correlation between US and DECT measurement of change in tophus volume
研究概览
简要总结
The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of gout based on the ACR/EULAR 2015 criteria
- •uricemia ≥6 mg/dL
- •warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR 2016 criteria
- •signature of the informed consent
- •social insurance affiliation
排除标准
- •pregnancy or breastfeeding
- •patient under legal guardianship
研究组 & 干预措施
UltraSonography and DECT
UltraSonography and DECT will be used in patient monitoring after 6, 12 and 24 months of treatment in order to evaluate the correlation between the 2 explorations for the measurement in tophus volume change.
Those are interventions that are not part of the standard care of the patients.
干预措施: ultrasonography (Procedure)
UltraSonography and DECT
UltraSonography and DECT will be used in patient monitoring after 6, 12 and 24 months of treatment in order to evaluate the correlation between the 2 explorations for the measurement in tophus volume change.
Those are interventions that are not part of the standard care of the patients.
干预措施: DECT (Procedure)
结局指标
主要结局
Correlation between US and DECT measurement of change in tophus volume
时间窗: after 24 months of treatment
Spearman rank correlation between the change in tophus volume after 24 months of treatment measured by ultrasonography or by DECT.
次要结局
- Correlation between US and DECT measurement of change in tophus volume(after 6 months, 12 months and 24 months of treatment)
- Correlation between the change of DECT urate score and the change in serum uric acid levels(after 6 months, 12 months and 24 months of treatment)
- Correlation between the change of DECT urate score and the number of gout attacks(after 6 months, 12 months and 24 months of treatment)
- Change of DECT urate score(after 6 months, 12 months and 24 months of treatment)
- Link between the change of DECT urate score and the persistence of the double contour sign(after 6 months, 12 months and 24 months of treatment)