None listed
Conditions
Brief summary
The TIM-TAM trial is a prospective, open-label, blinded endpoint randomised controlled trial assessing whether breast arterial calcification detected on routine mammography can be used to guide cardiovascular risk assessment and prevention in women. Participants will undergo automated assessment of mammograms for breast arterial calcification. Those with breast arterial calcification who meet eligibility criteria will be randomised to either BAC-guided enhanced cardiovascular risk management or standard care. The intervention group will receive BAC visualisation, cardiovascular risk assessment, personalised risk communication, education, and structured nurse-led risk management with follow-up over 36 months. The control group will receive standard cardiovascular risk management through usual care. Outcomes will include change in cardiovascular risk score, adherence to preventive therapy, and change in coronary plaque burden on coronary computed tomography
Interventions
Participants randomised to the intervention arm will receive breast arterial calcification (BAC)-guided enhanced cardiovascular risk management. This will include:
Visualisation - a visual representation of BAC (2D image of mammogram BAC shown) and explanation of cardiac risk based on CVD risk score.
CVD risk assessment - Routine bloods, anthropomorphic measures such as blood pressure and BMI and medical history to evaluate risk based on validated CVD risk scores
Education - Given nurse-led ad
Participants randomised to the intervention arm will receive breast arterial calcification (BAC)-guided enhanced cardiovascular risk management. This will include: Visualisation - a visual representation of BAC (2D image of mammogram BAC shown) and explanation of cardiac risk based on CVD risk score. CVD risk assessment - Routine bloods, anthropomorphic measures such as blood pressure and BMI and medical history to evaluate risk based on validated CVD risk scores Education - Given nurse-led advice on therapeutic targets for risk factors such as blood pressure and hyperlipdiaemia according to current guidelines Duration - Approximately 20- to 30 minutes The intervention will be delivered through a structured nurse-led cardiovascular risk management program, with follow-up reviews every 6 months over 36 months. Full risk assessment will only be performed at baseline and then every 12 months. Participants will receive a 3 month SMS or email reminder after their first visit. Ongoing management recommendations will be communicated to the participant and their usual medical practitioner where appropriate. Adherence will be assessed through participants survey and medication packet collection where possible. Guidelines used will be the 2023 Heart Foundation guidelines for CVD risk and 2026 AHA guidelines for dyslipidaemia
Sponsors
Dr Sheran Vasanthakumar (Victorian Heart Hospital)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Living in Australia Have a current breast cancer screening mammogram through Monash BreastScreen Victoria Able to provide informed consent Not pregnant, breastfeeding, or planning to become pregnant during the study If of childbearing potential, have a negative urine pregnancy test at the screening visit Breast arterial calcification positive on mammography following automated BAC assessment Considered by the investigator to be willing and able to comply with study requirements, including follow-up assessments and repeat coronary computed tomography where applicable
Exclusion criteria
Known cardiovascular disease High baseline cardiovascular disease risk Moderate to severe coronary disease on coronary computed tomography Cognitive impairment or any other condition affecting capacity to provide informed consent Estimated glomerular filtration rate less than 45 mL/min/1.73 m² Clinically significant non-cardiac disease or condition that, in the opinion of the investigator, would preclude participation Breast pathology or other mammographic factor that would limit interpretation of the mammogram Major allergy to iodine or iodinated contrast Pregnancy, breastfeeding, or planning pregnancy during the study
Outcome results
None listed