Clinical trial NCT05434858: Imagery as Biomarker of Gout
Official title: Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperuricemia
Keywords: Dual-energy computed tomography
hyperuricemia
gout
monosodium urate crystals
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Auckland University
First posted: 2022-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

Detailed description: Cross-sectional studies have shown that 17% to 86% of people with apparently asymptomatic hyperuricemia have ultrasound evidence of monosodium urate (MSU) crystal deposition. These observations suggest that this deposition constitutes the first stage of the clinical gout syndrome, which has led to a revised model of disease progression and staging. However, no longitudinal studies have been undertaken to determine whether such findings are needed for the development of gout, or to investigate pathological mechanisms responsible for the transition from asymptomatic crystalline deposit to gout. Only a prospective cohort study of people at risk who are carefully and regularly followed can answer such questions.

Dual-energy computed tomography (DECT) and ultrasound are the two imaging techniques that allow the visualization and quantification of MSU crystals. Ultrasound is the most widely used technique; it allows the identification of the deposit of crystals of on the surface of the cartilage (double contour sign) and of the tophi. The DECT can detect the deposition of MSU crystals in soft tissues as long as the amount of crystals exceeds the spatial resolution of the machine (about 250 μm).

The international collaborative study TIGER (Transitions in gout research study) aims to address the question of the predictive value of the deposition of MSU crystals "silent" in the development of gout, through an international cohort (7 countries) including 907 asymptomatic hyperuricaemic individuals. These individuals will have initial ultrasounds to investigate the presence of MSU crystal deposits and a 5-year follow-up. Given the aforementioned ultrasound reproducibility issues, DECT analyzes will be added to the baseline assessment of TIGER participants to provide exploratory data on DECT as a potential biomarker for the impending development of gout.

Eligibility 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

Primary outcomes:
measure: Odd ratios and its 95% confidence interval for the development of gout
timeFrame: 60 months
Secondary outcomes:
measure: Time until development of gout symptoms
timeFrame: 60 months
measure: Odd Ratio and its 95% confidence interval for gout development according to MSU volume
timeFrame: 60 months
measure: Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume
timeFrame: 60 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille Catholic Hospital
state: Nord Pas De Calais
Study officials:
affiliation: Lille Catholic University
name: Tristan Pascart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: