Skip to content

ARCHIMEDES study: Investigating the role of clonal haematopoiesis in atherosclerosis progression

ARCHIMEDES study: Investigating the role of clonal haematopoiesis in atherosclerosis progression

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000583549
Acronym
ARCHIMEDES
Enrollment
350
Registered
2024-05-07
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Clonal haematopoiesis of indeterminant potential (CHIP) is the technical term to describe the expansion of blood cells that results from changes to the genetic code that occur during normal ageing. We are only now beginning to understand what the implications of CHIP are for human health. CHIP has been linked to increased risk of cardiovascular disease. The aim of this study is to examine the blood vessels in the heart and factors in the blood to see if people who have CHIP have faster progression of atherosclerotic cardiovascular disease and other cardiovascular risk factors.

Interventions

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

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.

Sponsors

Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026