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Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

A

Ai Peng

Status

Active, not recruiting

Conditions

Advanced Gout
Intercritical Gout
Gout Flare
Asymptomatic Hyperuricemia

Study type

Observational

Funder types

Other

Identifiers

NCT05522504
SHSY-IEC-4.1/21-246/01

Details and patient eligibility

About

The purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

Full description

A number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from MSU deposition in the joint or tissue, leading to release NLRP3 inflammasome-mediated production of bioactive IL-1β. Further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. Recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. However, a global understanding of blood immune responses underlying gout is still unclear. Thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015
  • intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
  • advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
  • asymptomatic hyperuricemia: hyperuricemia in men was defined as SUA ≥ 420 mmol/L without any complications

Exclusion criteria

  • primary osteoarticular diseases
  • unwilling participation in the study
  • corticosteroids or indomethacin use in the past 3 months;
  • septic arthritis or another joint disease (such as rheumatoid arthritis);
  • impaired renal function (creatinine clearance <30 mL/min) and other conditions which may increase the level of blood uric acid

Trial design

600 participants in 5 patient groups

NC
Description:
healthy volunteer (Normal control):(1) aged between 18 and 80 years; (2) The serum UA levels were lower than 420 μmol/L for a man and 360 μmol/L for a woman at least one time during the two clinical tests for the samples collected with 1-week interval; (3) without any clinically diagnostic severe diseases including but not limited to a tumor, diabetes, cardiovascular, renal, nervous, digestive and mental disorders
AHU
Description:
Asymptomatic Hyperuricemia(AHU) were listed as follows: (1) aged between 18 and 80 years; (2) serum levels of UA were both greater than 420 μmol/L for a man and 360 μmol/L for a woman during the two clinical tests for the samples collected with about 1-week interval; (3) without self-reported history of the acute attack of gout; (4) without receiving medical treatment.
AGA
Description:
Acute Gout Attack (AGA) were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) and not receiving medical treatment 3 weeks prior to the blood collection.
IG
Description:
The intercritical gout (IG) remission criteria for gout patients were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (\<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) without tophi, imaging erosion, or chronic gouty arthritis
AG
Description:
The Advanced gout (AG) criteria for gout patients were listed as follows:(1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (\<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) with tophi, imaging erosion, or chronic gouty arthritis

Trial contacts and locations

1

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Central trial contact

Ai Peng, MD, PhD; Hongchen Gu, MD, PhD

Data sourced from clinicaltrials.gov

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