Using imaging to predict gout in people with high uric acid levels
Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout
This study is testing if using special imaging can help predict whether people with high uric acid levels will develop gout symptoms over five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Drugs / interventions | canakinumab |
| Locations | 1 site (Lille, Nord Pas De Calais) |
| Trial ID | NCT05434858 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate whether the presence of monosodium urate (MSU) crystal deposits, visualized through ultrasound and dual-energy computed tomography (DECT), is linked to the onset of symptomatic gout in individuals with hyperuricemia over a five-year period. By following a cohort of asymptomatic hyperuricemic individuals, the study seeks to understand the progression from crystal deposition to gout and the underlying mechanisms involved. The research will utilize advanced imaging techniques to quantify MSU crystals and assess their predictive value for developing gout symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with elevated serum urate levels but no current or previous symptoms of gout.
Not a fit: Patients with severe kidney impairment, autoimmune inflammatory arthritis, or those currently on uric acid-lowering treatments are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention for individuals at risk of developing gout, potentially preventing painful flare-ups.
How similar studies have performed: While cross-sectional studies have shown associations between MSU crystal deposition and gout, this longitudinal approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Serum urate level ≥ 80 mg/L on inclusion, * No current or previous clinical symptoms of gout (including clinically apparent flares or tophus), * Between 18 and 80 years old, * Able to give informed consent. Exclusion Criteria: * GFR (glomerular filtration rate) \<30 ml / min / 1.73 m² or dialysis, * Serious illness with a poor prognosis of less than 5 years, * Autoimmune inflammatory arthritis, * Change of geographical area within 5 years, * Previous analysis of synovial fluid showing crystals of MSU, * Presence of subcutaneous tophi, * Taking a hypouricaemic treatment (allopurinol, probenecid, benzbromarone, febuxostat, lesinurad), canakinumab, anakinra or colchicine, * Uricemia observed only after an acute decompensation of comorbidity * Pregnant or breastfeeding women
Where this trial is running
Lille, Nord Pas De Calais
- Lille Catholic Hospital — Lille, Nord Pas De Calais, France (Recruiting)
Study contacts
- Principal investigator: Tristan Pascart, MD, PhD — Lille Catholic University
- Study coordinator: Marie Desolere
- Email: desolere.marie@ghicl.net
- Phone: +33320225931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.