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Trial registered on ANZCTR


Registration number
ACTRN12621001018808
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
4/08/2021
Date last updated
5/07/2022
Date data sharing statement initially provided
4/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ARISTOCRAT Registry- The Australian natural history of pericoronary adipose tissue attenuation, radiomics and plaque by computed tomographic angiography
Scientific title
The Australian multi-centre registry for serial cardiac computed tomography angiography: A comprehensive exploration of the natural history of pericoronary adipose tissue attenuation and radiomics
Secondary ID [1] 304653 0
None
Universal Trial Number (UTN)
U1111-1267-3241
Trial acronym
ARISTOCRAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 322603 0
Coronary atherosclerosis 322604 0
Condition category
Condition code
Cardiovascular 320217 320217 0 0
Coronary heart disease
Cardiovascular 320444 320444 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
0
Target follow-up type
Days
Description of intervention(s) / exposure
Patients presenting for clinically indicated computed tomography coronary angiogram (CTCA) and had previously underwent CTCA more than 12 months prior are invited to participate in the ARISTOCRAT registry. Once consented, the serial CTCA scanning parameters (scanner, kVP, and reconstruction kernel) will be matched with the prior study. This registry will be conducted conducted for the next 5 years.

We will also collect data regarding participants' traditional cardiovascular risk factors, treatment with lipid-lowering therapy, and fasting lipid profile at the baseline and the serial CTCA study. Patient demographic data and traditional cardiovascular risk factors will be determined from patient questionnaires collected by CT nursing staffs at the time of CCTA scans and by review of electronic medical records. Fasting lipid profile done within 60 days of the CTCA will be collected retrospectively from medical records. These data will be collected via a secured online database in a deidentified manner. No further follow-up will be performed after the CTCA scan.
Intervention code [1] 321005 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328089 0
Percentage change in peri-coronary adipose tissue attenuation as assessed by cardiac CT angiogram.
Timepoint [1] 328089 0
At baseline and at the follow-up CTCA scan
Secondary outcome [1] 397582 0
Difference in radiomics parameters of peri-coronary adipose tissue assessed via CT coronary angiogram. This includes a total of 1,103 radiomic parameters; 44 first-order parameters describing the HU distribution of the tissue, 342 Gray-level co-occurrence matrix (GLCM) parameters describing the probability of given voxel pairs occurring next to each other, 33 Gray-level run-length matrix (GLRM) parameters enumerating the probability of identical voxel values being continuously next to each other, and 684 geometrical parameters describing the spatial complexity of the lesions.
Timepoint [1] 397582 0
At baseline at the follow-up CTCA.
Secondary outcome [2] 397583 0
Differences in radiomics parameters of coronary plaques assessed via CT coronary angiogram. This includes a total of 1,103 radiomic parameters; 44 first-order parameters describing the HU distribution of the tissue, 342 Gray-level co-occurrence matrix (GLCM) parameters describing the probability of given voxel pairs occurring next to each other, 33 Gray-level run-length matrix (GLRM) parameters enumerating the probability of identical voxel values being continuously next to each other, and 684 geometrical parameters describing the spatial complexity of the lesions.
Timepoint [2] 397583 0
At baseline and at the follow-up CTCA.
Secondary outcome [3] 397584 0
Change in coronary CT minimal lumen area of the non-obstructive plaque.
Timepoint [3] 397584 0
At baseline and at the follow-up CTCA.
Secondary outcome [4] 397585 0
Change in the size of low-attenuation plaque assessed via CT coronary angiogram.
Timepoint [4] 397585 0
At baseline and at the follow-up CTCA.
Secondary outcome [5] 397586 0
Change in plaque spotty calcification assessed via CT coronary angiogram.
Timepoint [5] 397586 0
At baseline and at the follow-up CTCA.
Secondary outcome [6] 397587 0
Change in plaque positive remodelling assessed via CT coronary angiogram.
Timepoint [6] 397587 0
At baseline and at the follow-up CTCA.

Eligibility
Key inclusion criteria
1. Patients who had previously underwent clinically indicated CT coronary angiogram at the same institution.
2. Patients who are able to provide written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Heart failure (New York Heart Association (NYHA) class IV) or left ventricular ejection fraction less than or equal to 35%.
2. Inability to provide informed consent.
3. Prior CABG and percutaneous revascularisation.
4. Atrial fibrillation.
5. Contrast allergy.
6. Dialysis or estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m².

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The descriptive summary will be presented as percentage frequencies for categorical variables and as mean ± SD (or as median with interquartile range) for continuous variables. Baseline characteristics will be compared using Chi-squared (or Fisher’s exact) test for categorical variables and independent t-test for continuous variables. Continuous variables will be tested for normality and appropriate non-parametric test will be used for variables not normally distributed. The % change in PCAT attenuation (primary endpoint) will be compared between the serial CTCAs, firstly, using independent t-test, then using ANCOVA, adjusting for the baseline measurement in appropriate form.
P-values of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
300
Accrual to date
131
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,SA,TAS,WA,VIC
Recruitment hospital [1] 19833 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 19834 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 19835 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 19836 0
Frankston Hospital - Frankston
Recruitment hospital [5] 19838 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [6] 19839 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [7] 19840 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [8] 22712 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 22713 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 34522 0
2170 - Liverpool
Recruitment postcode(s) [2] 34523 0
6150 - Murdoch
Recruitment postcode(s) [3] 34524 0
5042 - Bedford Park
Recruitment postcode(s) [4] 34525 0
3199 - Frankston
Recruitment postcode(s) [5] 34527 0
0810 - Tiwi
Recruitment postcode(s) [6] 34528 0
3168 - Clayton
Recruitment postcode(s) [7] 34529 0
3050 - Parkville
Recruitment postcode(s) [8] 37991 0
7000 - Hobart
Recruitment postcode(s) [9] 37992 0
0870 - Alice Springs
Recruitment outside Australia
Country [1] 23929 0
New Zealand
State/province [1] 23929 0
Auckland

Funding & Sponsors
Funding source category [1] 309015 0
University
Name [1] 309015 0
Monash Cardiovascular Research Centre, Victorian Heart Institute and Monash University
Country [1] 309015 0
Australia
Primary sponsor type
University
Name
Monash Cardiovascular Research Centre, Victorian Heart Institute and Monash University
Address
246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 309950 0
None
Name [1] 309950 0
Address [1] 309950 0
Country [1] 309950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308901 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 308901 0
Research Support Services
Level 2, i Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 308901 0
Australia
Date submitted for ethics approval [1] 308901 0
03/06/2021
Approval date [1] 308901 0
20/07/2021
Ethics approval number [1] 308901 0
Monash Health HREC Ref: 15087A

Summary
Brief summary
CT coronary angiogram (CTCA) is increasingly used as a non-invasive imaging tool to assess the efficacy of novel therapies on coronary inflammation as well as plaque progression, and it is imperative that we understand the natural history of pericoronary adipose tissue (PCAT) inflammation on serial assessment.

The ARISTOCRAT registry is a retrospective and prospective, open-label, multi-centre dynamic observational registry designed to directly assess the natural history of PCAT inflammation, coronary atherosclerosis, characteristics, and determinants of coronary plaque progression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112278 0
A/Prof Dennis Thiam Leong Wong
Address 112278 0
Monash Cardiovascular Research Centre, Victorian Heart Institute
Monash University and MonashHeart,
246 Clayton Road
Clayton, VIC 3168,
Country 112278 0
Australia
Phone 112278 0
+61 3 9594 6666
Fax 112278 0
Email 112278 0
[email protected]
Contact person for public queries
Name 112279 0
Kevin Cheng
Address 112279 0
Monash Cardiovascular Research Centre, Victorian Heart Institute
Monash University and MonashHeart,
246 Clayton Road
Clayton, VIC 3168,
Country 112279 0
Australia
Phone 112279 0
+61 3 9594 4543
Fax 112279 0
Email 112279 0
[email protected]
Contact person for scientific queries
Name 112280 0
Kevin Cheng
Address 112280 0
Monash Cardiovascular Research Centre, Victorian Heart Institute
Monash University and MonashHeart,
246 Clayton Road
Clayton, VIC 3168,
Country 112280 0
Australia
Phone 112280 0
+61 3 9594 4543
Fax 112280 0
Email 112280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.