HyperuricemiaNCT02502565
Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia
An observational study of Hyperuricemia, run by Washington D.C. Veterans Affairs Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Uric acid level
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: US Veterans with asymptomatic hyperuricemia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Howard University Hospital
Washington D.C., District of Columbia, 20060
WashingtonVAMC
Washington D.C., District of Columbia, 20422
About this study
Official title: 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.
- Conditions
- Hyperuricemia
- Being tested
- Uric acid level
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uric acid levelOther
| Study group | Role | What they receive |
|---|---|---|
| Uric Acid Level | Not described Receives: Other: Uric acid level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Urate Depositions Detected in Ultrasound
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Howard University, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Gail S Kerr, MD, FRCP, Principal investigator, Washington VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502565
- Sponsor's protocol ID
- MIRB #01580
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Ultrasound in Asymptomatic Hyperuricemia: Redefining Early Urate Disease
- ClinicalTrials.gov ID
- NCT02502565
- Acronym / sponsor ID
- MIRB #01580
- Conditions
- Hyperuricemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Howard University, AstraZeneca
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uric Acid Level | – | Other: Uric acid level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- US Veterans with asymptomatic hyperuricemia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uric acid level | Other | Uric Acid Level |
Primary outcome
Number of Urate Depositions Detected in Ultrasound
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Related trials for Hyperuricemia
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail S Kerr, MD, FRCP principal investigator
Washington VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia, run by Washington D.C. Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Urate Depositions Detected in Ultrasound (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.