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临床试验/NCT00584311
NCT00584311已完成不适用

MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs

University of South Florida2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
The primary endpoint is presence or absence of skeletal damage (on either MRI or US). The data will then be analyzed in the same fashion but by MRI and US independently.

研究概览

简要总结

Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain radiographic changes that are seen in patients with chronic gout, far less is known about the changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and ultrasound (US). Further, there is very little data on the MRI and US appearance of asymptomatic joints in patients with hyperuricemia and symptomatic gout.

There is vast emerging data to suggest that MRI and US are much more sensitive than plain radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these imaging devices have revolutionized the treatment of RA, for the earlier detection of the skeletal changes of RA often mandates more aggressive therapy. These same changes would often be missed by plain radiographs.

It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical of gout much sooner than would plain radiography. We also hypothesize that these same imaging techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic joints of patients with symptomatic gout in other joints. As was the case with RA, the expected results of this study would mandate more aggressive therapy of both gout and hyperuricemia.

Our primary aim of this proposal would be accomplished by studying patients with known gout and normal plain radiographs. Each patient would have their most frequently involved joint (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or tophi with cortical damage). Any signs that may portend future joint destruction such as synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be documented. In order to demonstrate the effects of hyperuricemic silent deposition, an asymptomatic joint from these same patients will be studied using these same imaging techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue edema, or joint effusions will be recorded. By demonstrating destructive, or potentially destructive, skeletal changes in the index joint or asymptomatic joint of a significant number of patients, we will show that patients who are left untreated on the basis of normal plain radiographs are likely to already have skeletal damage.

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

入选标准

  • Known history of gout

排除标准

  • History of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic arthritis)
  • History of another crystal induced arthritis (ex. pseudogout)
  • Any contraindication to receiving an MRI (ex. pacemaker)
  • Allergy to gadolinium contrast dye
  • Inability to give informed consent
  • Pregnant women
  • Erosive changes on initial screening x-ray of index joint
  • Serum Creatinine > 1.8 mg/dL at screening visit

结局指标

主要结局

The primary endpoint is presence or absence of skeletal damage (on either MRI or US). The data will then be analyzed in the same fashion but by MRI and US independently.

时间窗: 2 weeks

次要结局

  • The presence of erosions, tophi with cortical erosions, tophi without cortical erosions, bone marrow edema/reactive changes, soft tissue edema/swelling, synovial pannus, and joint effusions(2 weeks)

研究者

申办方类型
Other

研究点 (2)

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