Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001764123
Ethics application status
Approved
Date submitted
30/08/2019
Date registered
11/12/2019
Date last updated
8/01/2020
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cardiovascular risk in gout
Scientific title
The effect of acute gout on High-risk rupture-prone plaques (HRPs) determined by coronary computed tomography angiography (CCTA)
Secondary ID [1] 299151 0
None
Universal Trial Number (UTN)
Trial acronym
CRIG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 314214 0
Cardiovascular disease 314215 0
Condition category
Condition code
Musculoskeletal 312576 312576 0 0
Other muscular and skeletal disorders
Cardiovascular 312577 312577 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure is an attack of acute gout.
We will do patient questionnaires, metrology(swollen and tender joint count), blood tests, a Coronary CT Angiogram. The total duration of follow-up for each patient is 6 months.
Patients will be assessed monthly, the first and last visit might last hour, the other visits will last about 20 minutes.
Intervention code [1] 315425 0
Diagnosis / Prognosis
Comparator / control treatment
The group will be observed prospectively. Those who have a n acute flare of gout will be considered high risk those who do not, low risk (reference comparator).
Control group
Active

Outcomes
Primary outcome [1] 321230 0
Progression of high-risk rupture-prone plaques (HRPs) determined by coronary computed tomography angiography (CCTA)
Timepoint [1] 321230 0
6 months post enrollment
Secondary outcome [1] 374398 0
serum assay hs CRP
Timepoint [1] 374398 0
6 months post enrollment
Secondary outcome [2] 374399 0
serum assay IL-1R level,
Timepoint [2] 374399 0
6 months post enrollment
Secondary outcome [3] 374400 0
Ultrasound inflammation in joints
Timepoint [3] 374400 0
6 months post enrollment
Secondary outcome [4] 374401 0
serum assay ESR
Timepoint [4] 374401 0
6 months post enrollment
Secondary outcome [5] 376683 0
Metrology: this is a swollen and tender joint count.
Timepoint [5] 376683 0
6 months post enrollment
Secondary outcome [6] 376684 0
Gout Assessment Questionnaire 2.0
Timepoint [6] 376684 0
6 months post enrollment
Secondary outcome [7] 376685 0
Gout flare, using the definition described in the following reference: Gaffo AL, Dalbeth N, Saag K, et al. Validation of a Definition for Flare in Patients with Established Gout [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). The definition requiring fulfillment of at least 3 of 4 criteria (patient-defined gout flare, pain at rest score of >3 on a 0-10-point numerical rating scale, presence of at least 1 swollen joint, and presence of at least 1 warm joint)
Timepoint [7] 376685 0
6 months post enrollment.
Secondary outcome [8] 376696 0
Patient Global VAS
Timepoint [8] 376696 0
6 months post enrollment
Secondary outcome [9] 376697 0
patient pain VAS
Timepoint [9] 376697 0
6 months post enrollment.
Secondary outcome [10] 376698 0
Painful joints, Using a questionnaire which asks the participants to identify which joints are painful.
The tool is comonly used, and generally called a "painful joint count" based on the 68 joints of the Richie articular index, and uses a homunculous to as shown here: http://www.pmmonline.org/doctor/approach-to-clinical-assessment/examination/describing-joints
Timepoint [10] 376698 0
6 months post enrollment
Secondary outcome [11] 376699 0
Health Assessment Questionnaire
Timepoint [11] 376699 0
6 months post enrollment

Eligibility
Key inclusion criteria
A diagnosis of gout according to 2015 ACR criteria
requiring allopurinol therapy
45 years and a minimum of 2 risk factors, i.e. controlled hypertension, controlled diabetes, controlled dyslipidemia, obesity, age >55 years, and first degree relative with evidence of atherosclerosis <65 years will be recruited.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other forms of inflammatory arthritis (especially rheumatoid arthritis and psoriasis
Moderate to severe hepatic impairment
moderate renal impairment
Contra indication to allopurinol, especially azathioprine or 6-mercaptopurine use.
Pregnancy or breastfeeding.
Presence of any serious medical illness that may preclude follow up.
Inability to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
No pilot data is available to power this study, so a pragmatic decision has been made to include 14 patients to generate pilot data, assuming 50% will flare on allopurinol initiation. Descriptive statistics (such as mean with standard deviations for continuous variables, frequencies with percentages for categorical variables) will be used to summarise the two study groups. The differences between the study groups will be compared using t-test for continuous variables and chi-square tests for categorical variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/12/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
14
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14671 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 27699 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 303691 0
Charities/Societies/Foundations
Name [1] 303691 0
Spinnaker Health Research Foundation
Country [1] 303691 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr
Murdoch, Western Australia
6150
Country
Australia
Secondary sponsor category [1] 303798 0
None
Name [1] 303798 0
None
Address [1] 303798 0
Country [1] 303798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304216 0
South Metropolitan Health Service Human Research Ethics Committe
Ethics committee address [1] 304216 0
14 Barry Marshall Parade, Murdoch WA 6150
Ethics committee country [1] 304216 0
Australia
Date submitted for ethics approval [1] 304216 0
05/02/2019
Approval date [1] 304216 0
18/03/2019
Ethics approval number [1] 304216 0
RGS0000001463

Summary
Brief summary
This study aims to assess the cardiovascular risk in people with gout, through performing scanning the heart, and then performing the scan in 6 months. We will determine the impact of having an acute flare of gout on the scans, which is a surrogate of cardiovascular risk. This will help us understand the effect of acute inflammation on cardiovascular risk in gout,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96170 0
Dr Helen Keen
Address 96170 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia
6150
Country 96170 0
Australia
Phone 96170 0
+61861511140
Fax 96170 0
Email 96170 0
helen.keen@uwa.edu.au
Contact person for public queries
Name 96171 0
Mr Daniel Lightowler
Address 96171 0
Fiona Stanley Hospital
11 Robin Warren Drive,
Murdoch, Western Australia
6150
Country 96171 0
Australia
Phone 96171 0
+61 8 6152 2222
Fax 96171 0
Email 96171 0
daniel.lightowler@health.wa.gov.au
Contact person for scientific queries
Name 96172 0
Dr Helen Keen
Address 96172 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia
6150
Country 96172 0
Australia
Phone 96172 0
+61 8 6151 1140
Fax 96172 0
Email 96172 0
helen.keen@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics have not agreed to this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.