NCT02502565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

7 years

First QC Date

June 24, 2015

Last Update Submit

June 15, 2018

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Number of Urate Depositions Detected in Ultrasound

    2 years

Study Arms (1)

Uric Acid Level

Other: Uric acid level

Interventions

Uric acid levelOTHER
Uric Acid Level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

US Veterans with asymptomatic hyperuricemia

You may qualify if:

  • 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).
  • Patients, of matched gender and age, with normal uric acid levels will serve as controls.

You may not qualify if:

  • 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.
  • Patients with a diagnosis of skin psoriasis31, rheumatoid arthritis, or spondyloarthropathies will not be eligible to participate.
  • Patients who are on urate-lowering therapy.
  • Patients with 1 or 2 total knee replacements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

WashingtonVAMC

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

Uric Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gail S Kerr, MD, FRCP

    Washington VAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 20, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

US(2)