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

NCT ID: NCT00584311

Last Updated: 2008-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-05-31

Brief Summary

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.

Conditions

Gout

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

All patients (with no structural damage on the plain x-ray) will receive a MRI and Ultrasound (US) of their most involved joint and an asymptomatic joint.

Group Type: EXPERIMENTAL

MRI and Ultrasound

Intervention Type: OTHER

MRI and US of the joint

Interventions

MRI and Ultrasound

MRI and US of the joint

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Known history of gout

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

University of South Florida

Principal Investigators

John D. Carter, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

Other Identifiers

6123-G62368

Identifier Type: -

Identifier Source: secondary_id

6123-G62368

Identifier Type: -

Identifier Source: org_study_id