Gout
Conditions
Interventions
None listed
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Current serum urate level of >=8 mg/dl • No current or previous clinical symptoms of gout (including flares or clinically apparent tophi) • Aged between 18 and 80 years • Able to provide informed consent, according to requirements of local IRB/ethics committee
Exclusion criteria
Exclusion criteria: • eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ROLE OF MSU CRYSTAL DEPOSITION IN TRANSITION FROM HYPERURICEMIA TO GOUT - To determine whether ultrasound imaging evidence of MSU crystal deposition predicts development of symptomatic gout (according to the 2015 ACR/EULAR criteria [3]) over 5 years, in people who already have a high risk of gout due to elevated serum urate concentrations (>=8 mg/dL). - To describe the time-course for the development of gout over 5 years in people at risk of gout with and without MSU deposition on ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| TRANSITION FROM HYPERURICEMIA TO DE NOVO MSU CRYSTAL DEPOSITION - To determine factors that are associated with a higher risk of developing de novo MSU crystal deposition on ultrasound over 5 years, in people who have serum urate >=8 mg/dL. TRANSITION TO SYMPTOMATIC GOUT AND ASSOCIATED COMORBIDITIES - To identify risk factors (including clinical, genetic and biological) for the development of gout in people who are at high risk of gout with serum urate >=8 mg/dL. - To determine whether ultrasound evidence of MSU crystal deposition predicts development of medical comorbidities including cardiovascular disease and kidney disease Baseline variables collected: - demographic information as well as a physical exam including assessment of body mass index, blood pressure and the presence of tenderness and swelling using the 66/68 Tender Swollen Joint Count [5] and assessment for the absence of subcutaneous tophi. - Assessment of clinical risk factors, including exercise habits, consumption of sugar-sweetened beverages, fruit and alcohol, smoking history and family history of gout. I - In addition, medications and comorbidities (including those required for the gout-modified-Rheumatic Diseases Comorbidity Index (mRDCI) [6, 7]) will also be collected. - Health related quality of life (using the EuroQoL questionnaire [8]), hyperuricemia-related illness perception (using the Brief Hyperuricemia Perceptions Questionnaire (BIPQ) [9], beliefs about medicines (using the Beliefs about Medicines Questionnaire) [10] - body pain and foot pain over the past week using a 100 mm pain visual analogue scales (VAS), activity limitation using the Health Assessment Questionnaire - II (HAQ-II) [11] and foot-related pain and disability using the Manchester Foot Pain and Disability Index (MFPDI) [12] will be assessed. - Laboratory tests: creatinine and C-reactive protein (CRP), serum urate, IL-1β. - For those participants who agree to genetic testing, candidat | — |
Countries
Netherlands
Outcome results
None listed