Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT05546593
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EchoGoutte
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-A01121-42 | REGISTRY | IDRCB | View |