Clinical trial NCT05546593: Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout
Official title: Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gout
Keywords: Gout
Ultrasound
Microcrystal disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in Rheumatology or Internal Medicine Departments of Ambroise Paré hospital-APHP.

Brief summary: Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.

Detailed description: Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout. This is a transversal bicentric study, including patients who consulted for gout in the Rheumatology and Internal Medicine department of Ambroise Paré Hospital. Inclusion criteria were adult patients with a diagnosis of gout according to ACR/EULAR 2015 criteria and able to give informed consent. Exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without French social insurance. Patients had clinical and ultrasound examination, realized by two physicians blinded from each other.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria were adult patients with a diagnosis of gout according to ACR/EULAR 2015 criteria and able to give informed consent. Exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without French social insurance.

Exclusion Criteria:

-

Primary outcomes:
measure: Ultrasound lesion of gout as defined by OMERACT (Outcome Measures in Rheumatology)
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Rhumatology department, Ambroise Paré hospital - APHP
state: Aphp
Study officials:
affiliation: Rhumatology department, Ambroise Paré hospital - APHP
name: Maria-Antonietta D'AGOSTINO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: