Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001407886
Ethics application status
Approved
Date submitted
26/08/2021
Date registered
19/10/2021
Date last updated
19/10/2021
Date data sharing statement initially provided
19/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Association of Breast Arterial Calcification with Cardiovascular Disease
Scientific title
Association of Breast Arterial Calcification with Cardiovascular Disease
Secondary ID [1] 304858 0
APP1197028 - NHMRC Investigator Grant
Secondary ID [2] 304859 0
App #: MBI21-4172410363 - Monash/Baker Seed Grant
Universal Trial Number (UTN)
Trial acronym
BAC I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 322959 0
Breast Arterial Calcification 323647 0
Condition category
Condition code
Cardiovascular 320536 320536 0 0
Coronary heart disease
Cardiovascular 320537 320537 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 320538 320538 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 321249 0
Early Detection / Screening
Comparator / control treatment
The control group will be patients who do not have a previous mammogram with identifiable breast arterial calcification. Mammograms were previously conducted for an alternate clinical reason.
The control group will also undergo a cardiac CT scan which will be conducted in an identical manner to the breast arterial calcification group.
Control group
Active

Outcomes
Primary outcome [1] 328363 0
Presence of coronary artery plaque
Timepoint [1] 328363 0
At time of research cardiac CT
Primary outcome [2] 328994 0
Composite of coronary artery plaque quantity and composition (e.g. calcified plaque, high risk plaque)
Timepoint [2] 328994 0
At time of research cardiac CT
Secondary outcome [1] 398715 0
Volume of peri-coronary adipose tissue
Timepoint [1] 398715 0
At time of research cardiac CT
Secondary outcome [2] 401086 0
Density of peri-coronary adipose tissue
Timepoint [2] 401086 0
At time of research cardiac CT

Eligibility
Key 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

Minimum age
40 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Preliminary studies suggest patients with BAC will have greater presence and progression of their calcium score and have increased risk of major adverse cardiovascular events. The expected prevalence of BAC is estimated to be up to 40%. We have identified 138 patients sourced from the Monash Health imaging database that had CCTA and mammography performed within 3 months of each other and aim to recruit all willing patients. If we capture 100 patients and assuming a 40-60% split between BAC and no BAC, we expect that BAC patients will have increased plaque progression. Assuming a control group (no BAC) progression rate of 2.5 ± 8.4 Agatston units and in the BAC group 11.7 ± 20.5 Agatston units, a total of 34 no BAC and 51 BAC will be required to achieved 80% power at an alpha of 0.05 to demonstrate a difference.

T-tests, ANOVA or chi-square tests for between group comparisons as appropriate. Linear regression will be performed to evaluate association between plaque, inflammation and BAC. Linear mixed models (to account for repeated measures and within patient correlation) will be performed for analysis of plaque progression. Multivariable modelling will be performed to adjust for clinically relevant factors including age, risk factors and medical therapy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20074 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 34780 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 309232 0
Government body
Name [1] 309232 0
National Health and Medical Research Council
Country [1] 309232 0
Australia
Funding source category [2] 309417 0
Other
Name [2] 309417 0
Baker Heart and Diabetes Institute
Country [2] 309417 0
Australia
Funding source category [3] 309713 0
University
Name [3] 309713 0
Monash University
Country [3] 309713 0
Australia
Primary sponsor type
University
Name
Monash Cardiovascular Research Centre, Monash University
Address
246 Clayton Road, Clayton, VIC 3123
Country
Australia
Secondary sponsor category [1] 310210 0
None
Name [1] 310210 0
Address [1] 310210 0
Country [1] 310210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309079 0
Monash Health Human Research Ethics and Site Authorisation
Ethics committee address [1] 309079 0
Ethics committee country [1] 309079 0
Australia
Date submitted for ethics approval [1] 309079 0
18/11/2020
Approval date [1] 309079 0
06/04/2021
Ethics approval number [1] 309079 0

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

Contacts
Principal investigator
Name 112902 0
Dr Nitesh Nerlekar
Address 112902 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 112902 0
Australia
Phone 112902 0
+61 3 9594 6666
Fax 112902 0
Email 112902 0
[email protected]
Contact person for public queries
Name 112903 0
Nitesh Nerlekar
Address 112903 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 112903 0
Australia
Phone 112903 0
+61 3 9594 6666
Fax 112903 0
Email 112903 0
[email protected]
Contact person for scientific queries
Name 112904 0
Nitesh Nerlekar
Address 112904 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 112904 0
Australia
Phone 112904 0
+61 3 9594 6666
Fax 112904 0
Email 112904 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
Individual participant data will remain de-identified and confidential through the study period. De-identified non-aggregate participant data will no be available in the published manuscript or on request. Only aggregate data in the published manuscript.


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.