Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000583549
Ethics application status
Approved
Date submitted
19/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ARCHIMEDES study: Investigating the role of clonal haematopoiesis in atherosclerosis progression
Scientific title
ARCHIMEDES study: Investigating the role of clonal haematopoiesis in atherosclerosis progression
Secondary ID [1] 310097 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ARCHIMEDES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 333609 0
Condition category
Condition code
Cardiovascular 330296 330296 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
Participants in the Archimedes study will be recruited from a population of volunteers with no prior heart attack of stroke. The DNA from 2500 participants will be screened and from this all samples identified as having CHIP variants will be identified. Having CHIP variants does not mean the person has any specific condition. The participants identified by this sample screening will be sent information with the aim of enrolling them in the study for basic cardiovascular assessment. Therefore the risk of having cardiovascular disease and the amount and type of coronary artery plaque will be determined for each individual that enrols. This will provide information on whether they are at risk of having a major cardiovascular event. In parallel, a group of individuals from the same screened cohort, without the CHIP variants, will be enrolled as controls. The cardiovascular risk assessment will be performed by using questionnaires and a physical examination of blood pressure and blood sampling. Participants will also undergo cardiac imaging by computed tomography coronary angiogram. Additional questionnaires will be used to determine quality of life and additional blood samples will be used for laboratory analysis of genetic and biochemical information. These parameters will be collected at baseline and 18 months later.
Intervention code [1] 328456 0
Not applicable
Comparator / control treatment
The control group is participants without CHIP-associated genetic variants detected during a DNA screen. Control participants will undergo the same tests as the CHIP +ve participants.
Control group
Active

Outcomes
Primary outcome [1] 338038 0
The primary study endpoint is change in non-calcified plaque volume between baseline and 18 months which will be measured from analysis of images obtained by computed tomography coronary angiogram.
Timepoint [1] 338038 0
Non-calcified plaque will be measured on images collected at baseline and 18 months post-baseline measurements.
Secondary outcome [1] 434278 0
Plaque composition will be measured from analysis of images obtained by computed tomography coronary angiogram. Specific measures will include: Total atheroma volume, calcified plaque volume percent atheroma volume, maximum lumen stenosis and Leaman score
Timepoint [1] 434278 0
Baseline and 18 months post-baseline measurements.
Secondary outcome [2] 434280 0
Adipose inflammatory markers: pericoronary adipose tissue CT attenuation and epicardial fat volume and density will be measured from analysis of images obtained by computed tomography coronary angiogram.
Timepoint [2] 434280 0
Baseline and 18 months post-baseline measurements.
Secondary outcome [3] 434281 0
Quality of life will be measured using the AQoL-8D questionnaire. The international physical activity questionnaire will be used for estimating the level of daily activity. The PHQ-9 and GAD-7 questionnaire will be used to assess levels of anxiety. The Epworth sleepiness scale and OSA50 questionnaires will be used to assess sleep patterns.
Timepoint [3] 434281 0
Baseline and 18 months post-baseline measurements.
Secondary outcome [4] 434282 0
Cardiovascular risk score will be determined by using the Australian CVD risk calculator.
Timepoint [4] 434282 0
Baseline and 18 months post-baseline measurements.
Secondary outcome [5] 434283 0
Circulating high sensitivity C reactive protein (CRP) will be measured in blood samples sent to the local pathology laboratory.
Timepoint [5] 434283 0
Baseline and 18 months post-baseline measurements.
Secondary outcome [6] 434289 0
Circulating lipids will be assessed in blood samples sent to the local pathology laboratory. The main lipids of interest are total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides, and lipoprotein (a).
Timepoint [6] 434289 0
Baseline and 18 months post-baseline measurements.

Eligibility
Key inclusion criteria
*Capable of providing written informed consent and willing to adhere to all protocol requirements
* Male or female 65 years of age or older at time of DNA sample provision to ABC Study
* Resident of Victoria, Australia
* Genetic data report from DNA screen available
* No self-reported history of heart attack or stroke
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unable to provide written informed consent
* Unable or unwilling to adhere to all protocol requirements
* Currently prescribed or have a requirement for lipid lowering therapy – statins, fibrates, ezetimibe, PCSK9i, bile acid resins, niacin, red yeast rice extract
* Calcium score found on baseline CTCA =400 HU
* Estimated GFR of <45 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
* Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study
* Major allergy to iodine

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26449 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 42427 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 314260 0
Government body
Name [1] 314260 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 314260 0
Australia
Funding source category [2] 316428 0
University
Name [2] 316428 0
Monash University
Country [2] 316428 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318534 0
None
Name [1] 318534 0
None
Address [1] 318534 0
Country [1] 318534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313379 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313379 0
Ethics committee country [1] 313379 0
Australia
Date submitted for ethics approval [1] 313379 0
24/06/2023
Approval date [1] 313379 0
23/08/2023
Ethics approval number [1] 313379 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127942 0
Prof Stephen Nicholls
Address 127942 0
Monash Heart, Level 3, Victorian Heart Hospital, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 127942 0
Australia
Phone 127942 0
+61 3 7511 1682
Fax 127942 0
Email 127942 0
[email protected]
Contact person for public queries
Name 127943 0
Dr Kristen Bubb
Address 127943 0
Monash University, Level 2 Victorian Heart Hospital, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 127943 0
Australia
Phone 127943 0
+61 3 75111857
Fax 127943 0
Email 127943 0
[email protected]
Contact person for scientific queries
Name 127944 0
Dr Kristen Bubb
Address 127944 0
Monash University, Level 2 Victorian Heart Hospital, 631 Blackburn Rd, Clayton, Victoria, 3168
Country 127944 0
Australia
Phone 127944 0
+61 3 75111857
Fax 127944 0
Email 127944 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22239Informed consent form    386221-(Uploaded-19-04-2024-14-24-07)-Study-related document.doc
22240Ethical approval    386221-(Uploaded-19-04-2024-13-53-11)-Study-related document.pdf



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.