Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia

Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease

An observational study to evaluate the prevalence of US changes of gout in the joints and tendons of patients with different degrees of asymptomatic hyperuricemia. The investigators' findings may support the extension of the spectrum of urate disease, and define a subset of patients that may benefit from early urate-lowering therapy.

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia
• Intervention / Treatment: Other: Uric acid level

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University Hospital
    • Washington, District of Columbia, United States, 20422
      • WashingtonVAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

US Veterans with asymptomatic hyperuricemia

Description

Inclusion Criteria:

1. Patients must have at least one serum uric acid level l ≥ 7.0 mg/dL within the last two years without a clinical diagnosis of gout per American College of Rheumatology criteria30 (appendix A).
2. Patients, of matched gender and age, with normal uric acid levels will serve as controls.

Exclusion Criteria:

1. Patients who meet or have met the ACR criteria for Gout, unable to read English, and/or have terminal illness will not be eligible to participate in the study.
2. Patients with a diagnosis of skin psoriasis31, rheumatoid arthritis, or spondyloarthropathies will not be eligible to participate.
3. Patients who are on urate-lowering therapy.
4. Patients with 1 or 2 total knee replacements.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uric Acid Level	Other: Uric acid level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Urate Depositions Detected in Ultrasound	2 years

Collaborators and Investigators

• Sponsor: Washington D.C. Veterans Affairs Medical Center
• Collaborators: AstraZeneca; Howard University
• Investigators: Principal Investigator: Gail S Kerr, MD, FRCP, Washington VAMC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Uric Acid
• Other Study ID Numbers: MIRB #01580