Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort

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....

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Main Authors: Maria-Antonietta D’Agostino, Tuhina Neogi, Hilde Berner Hammer, Lene Terslev, Lisa Stamp, Tony Merriman, Sarah Stewart, Nicola Dalbeth, Anne Horne, John D Fitzgerald, Mariano Andrés, Tristan Pascart, Janitzia Vázquez-Mellado, Greg Gamble, William Taylor, Julia Martin, Changgui Li, Borislav Mihov, Mingshu Sun, Eleonora Norkuviene, Isabel Su, Maria-Luisa Peral-Garrido, Tillman Uhlig
Format: Article
Language:English
Published: BMJ Publishing Group 2024-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/11/e090415.full
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author Maria-Antonietta D’Agostino
Tuhina Neogi
Hilde Berner Hammer
Lene Terslev
Lisa Stamp
Tony Merriman
Sarah Stewart
Nicola Dalbeth
Anne Horne
John D Fitzgerald
Mariano Andrés
Tristan Pascart
Janitzia Vázquez-Mellado
Greg Gamble
William Taylor
Julia Martin
Changgui Li
Borislav Mihov
Mingshu Sun
Eleonora Norkuviene
Isabel Su
Maria-Luisa Peral-Garrido
Tillman Uhlig
author_facet Maria-Antonietta D’Agostino
Tuhina Neogi
Hilde Berner Hammer
Lene Terslev
Lisa Stamp
Tony Merriman
Sarah Stewart
Nicola Dalbeth
Anne Horne
John D Fitzgerald
Mariano Andrés
Tristan Pascart
Janitzia Vázquez-Mellado
Greg Gamble
William Taylor
Julia Martin
Changgui Li
Borislav Mihov
Mingshu Sun
Eleonora Norkuviene
Isabel Su
Maria-Luisa Peral-Garrido
Tillman Uhlig
author_sort Maria-Antonietta D’Agostino
collection DOAJ
description 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.
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spelling doaj-art-c7bf9cd82f1c4b178d759a3ac08825e92025-08-20T02:13:58ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2024-090415Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohortMaria-Antonietta D’Agostino0Tuhina Neogi1Hilde Berner Hammer2Lene Terslev3Lisa Stamp4Tony Merriman5Sarah Stewart6Nicola Dalbeth7Anne Horne8John D Fitzgerald9Mariano Andrés10Tristan Pascart11Janitzia Vázquez-Mellado12Greg Gamble13William Taylor14Julia Martin15Changgui Li16Borislav Mihov17Mingshu Sun18Eleonora Norkuviene19Isabel Su20Maria-Luisa Peral-Garrido21Tillman Uhlig2218 Università Cattolica del Sacro Cuore Facoltà di Medicina e Chirurgia, Roma, Italy10 Boston University School of Medicine, Boston, Massachusetts, USA15 Diakonhjemmet Hospital, Oslo, Norway14 Rigshospitalet, Kobenhavn, Denmark6 Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand5 School of Medical Sciences, University of Otago, Dunedin, New Zealand1 Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand4 The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand2 Department of Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand13 Medicine, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA8 Alicante Institute for Health and Biomedical Research, Alicante, Spain7 Department of Rheumatology, Lille Catholic University, Lille, France12 General Hospital of Mexico, Ciudad de Mexico, Mexico2 Department of Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand3 Rehabilitation Teaching & Research Unit, Department of Medicine, University of Otago Wellington, Wellington, New Zealand19 Auckland District Health Board, Auckland, New Zealand21 Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China4 The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand20 Qingdao University, Qingdao, Shandong, China11 Lithuanian University of Health Sciences, Kaunas, Lithuania4 The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand9 Vinalopó University Hospital, Elche, Spain17 Universitetet i Oslo, Oslo, NorwayIntroduction 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.https://bmjopen.bmj.com/content/14/11/e090415.full
spellingShingle Maria-Antonietta D’Agostino
Tuhina Neogi
Hilde Berner Hammer
Lene Terslev
Lisa Stamp
Tony Merriman
Sarah Stewart
Nicola Dalbeth
Anne Horne
John D Fitzgerald
Mariano Andrés
Tristan Pascart
Janitzia Vázquez-Mellado
Greg Gamble
William Taylor
Julia Martin
Changgui Li
Borislav Mihov
Mingshu Sun
Eleonora Norkuviene
Isabel Su
Maria-Luisa Peral-Garrido
Tillman Uhlig
Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
BMJ Open
title Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
title_full Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
title_fullStr Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
title_full_unstemmed Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
title_short Development of gout in people with asymptomatic hyperuricemia: study protocol for a 5-year prospective cohort
title_sort development of gout in people with asymptomatic hyperuricemia study protocol for a 5 year prospective cohort
url https://bmjopen.bmj.com/content/14/11/e090415.full
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