Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia

Hyperuricemia Clinical Trial

Official title:

Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02502565
• Other study ID #: MIRB #01580
• Status: Active, not recruiting
• Start date: January 2012
• Est. completion date: March 2019

Study information

• Verified date: June 2018
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Other:
• Uric acid level

Locations

Country	Name	City	State
United States	Howard University Hospital	Washington	District of Columbia
United States	WashingtonVAMC	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center	AstraZeneca, Howard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Urate Depositions Detected in Ultrasound		2 years