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Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia

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ClinicalTrials.gov Identifier: NCT02502565
Recruitment Status : Active, not recruiting
First Posted : July 20, 2015
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Howard University
AstraZeneca
Information provided by (Responsible Party):
Washington D.C. Veterans Affairs Medical Center

Brief 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.

Condition or disease Intervention/treatment
Hyperuricemia Other: Uric acid level

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease
Actual Study Start Date : January 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Uric Acid

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



Primary Outcome Measures :
  1. Number of Urate Depositions Detected in Ultrasound [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
US Veterans with asymptomatic hyperuricemia
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502565


Locations
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
WashingtonVAMC
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Howard University
AstraZeneca
Investigators
Principal Investigator: Gail S Kerr, MD, FRCP Washington VAMC

Responsible Party: Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02502565     History of Changes
Other Study ID Numbers: MIRB #01580
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs