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Association of Breast Arterial Calcification with Cardiovascular Disease

Association of Breast Arterial Calcification with Cardiovascular Disease

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001407886
Acronym
BAC I
Enrollment
100
Registered
2021-10-19
Start date
2021-11-01
Completion date
2022-06-01
Last updated
2021-10-26

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

Conditions

None listed

Brief summary

Cardiovascular disease (CVD) is the main cause of death in women. Current ways to check for CVD in women are unreliable. Breast artery calcification (BAC) is build-up of calcium in the blood vessels of the breast. It can be seen on mammograms and is related to CVD. The way in which CVD develops and progresses is not clear. A cardiac CT scan is a specialised X-ray test that allows you to look at the arteries of the heart. Using a computer software we can measure the plaque which blocks arteries, some of which are 'high risk plaque' meaning they are associated with future heart attacks. We can also measure other markers such as peri-coronary adipose tissue which is indicative of inflammation that can predict the development of plaque. In this study we will recruit patients with previous mammogram and a cardiac CT to have another cardiac CT to look at the change in plaque and compare BAC to no BAC. This will allow us to examine the association of BAC with coronary plaque presence and progression. We expect that patients with BAC will have more plaque, inflammation and high risk plaque on their previously conducted clinical cardiac CT. We also expect patients with BAC to show greater progression of these parameters on their research cardiac CT when compared to their previously conducted clinical cardiac CT.

Interventions

This study will be looking to see whether the presence of breast arterial calcification (BAC) on digital mammography is predictive of cardiovascular disease (CVD) in women. Patients who have previously undergone digital mammography and a coronary computed tomography angiography (CCTA) scan are invited to participate in the BAC I Study. Once consented, participants will be invited to undergo a single research CCTA scan at Monash Heart, Monash Health at the earliest timepoint possible. Scans will

This study will be looking to see whether the presence of breast arterial calcification (BAC) on digital mammography is predictive of cardiovascular disease (CVD) in women. Patients who have previously undergone digital mammography and a coronary computed tomography angiography (CCTA) scan are invited to participate in the BAC I Study. Once consented, participants will be invited to undergo a single research CCTA scan at Monash Heart, Monash Health at the earliest timepoint possible. Scans will be conducted by qualified medical imaging technologists and where possible, the CCTA scanning parameters (scanner, kVP, and reconstruction kernel) will be matched with the previously conducted CCTA. The CCTA scan itself takes 5-10 minutes however participants may require observation and therfore it may take 2-3 hours from start to finish. Findings of the research CCTA will be compared to those of the previously conducted CCTA to determine the presence and development of CVD. At time of CCTA, we will also collect data regarding participants' traditional cardiovascular risk factors, treatment with lipid-lowering therapy and demographic data using patient questionnaires and review of electronic medical records where necessary. This data will be collected via secure online database with patients information remaining de-identifed. No further follow-up will be performed after the CTCA scan. Previously conducted mammograms will be accessed using a secure online database, with images reviewed to determine the presence of BAC. There is no specified time period from which retrospective data will be collected.

Sponsors

Monash Cardiovascular Research Centre, Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Have had breast mammography and clinically indicated Coronary Computed Tomography Angiography (CCTA) at Monash Health. 2. Agreeable to undergo single research CCTA at Monash Health. 3. Agree to collection of blood for storage

Exclusion criteria

1. Inability to provide informed consent or unwillingness to undergo CCTA 2. Previous allergic reaction to contrast media. 3. Severe renal impairment (eGFR <30mL/min). 4. Asthma or Chronic Respiratory Disease in patients who may need beta-blockade to lower heart rate. 5. Women who may be pregnant (premenopausal women will undergo pregnancy testing).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026