TY - JOUR
T1 - Development of gout in people with asymptomatic hyperuricemia
T2 - study protocol for a 5-year prospective cohort
AU - Stewart, Sarah
AU - Gamble, Greg
AU - Taylor, William
AU - Su, Isabel
AU - Merriman, Tony
AU - Mihov, Borislav
AU - Horne, Anne
AU - Stamp, Lisa
AU - Pascart, Tristan
AU - Andrés, Mariano
AU - Peral-Garrido, Maria-Luisa
AU - Neogi, Tuhina
AU - Norkuviene, Eleonora
AU - Vazquez-Mellado, Janitzia
AU - FitzGerald, John D
AU - Terslev, Lene
AU - Hammer, Hilde Berner
AU - Uhlig, Tillman
AU - D'Agostino, Maria-Antonietta
AU - Martin, Julia
AU - Sun, Mingshu
AU - Li, Changgui
AU - Dalbeth, Nicola
N1 - COPECARE
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/11/7
Y1 - 2024/11/7
N2 - INTRODUCTION: The central biochemical cause of gout is hyperuricemia (elevated serum urate levels). Ultrasound features of monosodium urate (MSU) crystal deposition are common in people with asymptomatic hyperuricemia. However, it is unclear whether this is a precondition for the development of gout. This study aims to determine whether ultrasound imaging evidence of MSU crystal deposition predicts development of symptomatic gout over 5 years, in people who already have an increased risk of gout due to elevated serum urate concentrations (≥8 mg/dL).METHODS AND ANALYSIS: This is a prospective, international, multicentre study. The study population comprises over 250 participants with asymptomatic hyperuricemia (serum urate ≥8.0 mg/dL). After the baseline assessments, participants are followed for 5 years or until the development of gout, defined by the 2015 American College of Rheumatology/European Alliance of Associations for Rheumatology gout classification criteria. Baseline assessments include anthropomorphic measures, laboratory tests, questionnaires, blood and urine specimen collection, plain radiographs of the feet and standardised ultrasound scans of the lower limbs, scored according to the Outcomes in Rheumatology (OMERACT) gout ultrasound scoring system. The primary outcomes are the development of gout and time course for development of gout in people with and without ultrasound evidence of MSU crystal deposition. Exploratory analyses will examine clinical, genetic and biological factors associated with development of MSU crystal deposition and gout.ETHICS AND DISSEMINATION: This study protocol was approved by the New Zealand Ministry of Health Southern Health and Disability Ethics Committee (MEC/05/10/130/AM16) on 18 December 2018. The findings from this study will be published in peer-reviewed journals and will be presented at national and international conferences.TRIAL REGISTRATION NUMBER: ACTRN12619000915156.
AB - INTRODUCTION: The central biochemical cause of gout is hyperuricemia (elevated serum urate levels). Ultrasound features of monosodium urate (MSU) crystal deposition are common in people with asymptomatic hyperuricemia. However, it is unclear whether this is a precondition for the development of gout. This study aims to determine whether ultrasound imaging evidence of MSU crystal deposition predicts development of symptomatic gout over 5 years, in people who already have an increased risk of gout due to elevated serum urate concentrations (≥8 mg/dL).METHODS AND ANALYSIS: This is a prospective, international, multicentre study. The study population comprises over 250 participants with asymptomatic hyperuricemia (serum urate ≥8.0 mg/dL). After the baseline assessments, participants are followed for 5 years or until the development of gout, defined by the 2015 American College of Rheumatology/European Alliance of Associations for Rheumatology gout classification criteria. Baseline assessments include anthropomorphic measures, laboratory tests, questionnaires, blood and urine specimen collection, plain radiographs of the feet and standardised ultrasound scans of the lower limbs, scored according to the Outcomes in Rheumatology (OMERACT) gout ultrasound scoring system. The primary outcomes are the development of gout and time course for development of gout in people with and without ultrasound evidence of MSU crystal deposition. Exploratory analyses will examine clinical, genetic and biological factors associated with development of MSU crystal deposition and gout.ETHICS AND DISSEMINATION: This study protocol was approved by the New Zealand Ministry of Health Southern Health and Disability Ethics Committee (MEC/05/10/130/AM16) on 18 December 2018. The findings from this study will be published in peer-reviewed journals and will be presented at national and international conferences.TRIAL REGISTRATION NUMBER: ACTRN12619000915156.
KW - Humans
KW - Gout/epidemiology
KW - Hyperuricemia/epidemiology
KW - Prospective Studies
KW - Ultrasonography
KW - Uric Acid/blood
KW - Asymptomatic Diseases
KW - Male
KW - Female
KW - Multicenter Studies as Topic
KW - Research Design
KW - Adult
KW - Middle Aged
UR - http://www.scopus.com/inward/record.url?scp=85209162390&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-090415
DO - 10.1136/bmjopen-2024-090415
M3 - Journal article
C2 - 39510780
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e090415
ER -