Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000822381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/05/2026
Date registered
Help: Date registered
8/07/2026
Date last updated
Help: Date last updated
8/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Mammogram-detected breast arterial calcification to guide heart disease risk assessment and prevention in women: the TIM-TAM trial (Targeted Identification of Myocardial risk Through Assessment with Mammography)
Scientific title
Breast arterial calcification guided cardiovascular screening and risk management in women – Targeted Identification of Myocardial risk Through Assessment with Mammography: the TIM-TAM trial
Additional trial identifiers [1] 317309 0
Nil
Universal Trial Number (UTN)
Trial acronym
TIM-TAM
Related trial records

Health condition
Health condition(s) studied:
coronary artery disease 341945 0
Condition category
Condition code
Cardiovascular 338012 338012 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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
Intervention code [1] 334087 0
Early detection / Screening
Description of the comparator or control
Participants randomised to the control group will be advised to continue usual care with their regular medical practitioner for standard cardiovascular risk management as they would have done usually. They will undergo scheduled study follow-up assessments over 36 months for cardiovascular risk factors, adherence, clinical outcomes, and study endpoints, however, will not have any direct management or advice for cardiovascular risk.
Participants in the control arm will have follow up 12 monthly.
Control group
Active

Outcomes
Primary outcome [1] 345435 0
Change in cardiovascular disease risk score
Timepoint [1] 345435 0
Change in calculated cardiovascular disease risk score from baseline to 12 months , 24 months and 36 months
Primary outcome [2] 345436 0
Change in coronary plaque burden on coronary computed tomography
Timepoint [2] 345436 0
Change in coronary plaque burden assessed by coronary computed tomography from baseline to 36 months.
Primary outcome [3] 345688 0
Change in coronary plaque composition on coronary computed tomography
Timepoint [3] 345688 0
Change in coronary plaque composition assessed by coronary computed tomography from baseline to 36 months.
Secondary outcome [1] 461703 0
Proportion of participants achieving overall guideline-directed targets for cardiovascular risk factors, including LDL cholesterol, blood pressure, HBA1c, BMI and smoking status. (This will be assessed as a composite)
Timepoint [1] 461703 0
Cardiovascular risk assessment at 12, 24 and 36 months

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed until the intervention is assigned, using a centralised web-based randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised in a 1:1 ratio to the intervention or control group using a computer-generated random allocation sequence. Randomisation will be performed through a centralised web-based randomisation system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be performed according to a pre-specified statistical analysis plan. Analyses will follow an intention-to-treat approach. Continuous variables will be summarised using mean and standard deviation, or median and interquartile range where appropriate. Categorical variables will be summarised using frequencies and percentages.
Primary outcomes, including change in cardiovascular disease risk score and change in coronary plaque volume, will be analysed using linear mixed models and/or analysis of covariance, adjusting for baseline values. Between-group comparisons for adherence and categorical secondary outcomes will be performed using chi-square tests or equivalent methods. Continuous secondary outcomes will be compared using t-tests, analysis of variance, or non-parametric tests as appropriate.
Time-to-event outcomes, including major adverse cardiovascular events, will be analysed using Cox proportional hazards models where applicable. Economic evaluation will include assessment of cost-effectiveness, including calculation of the incremental cost-effectiveness ratio comparing BAC-guided management with standard care over 3 years. Missing data will be handled using multiple imputation where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
634
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321878 0
Government body
Name [1] 321878 0
NHMRC
Country [1] 321878 0
Australia
Primary sponsor type
Individual
Name
Dr Sheran Vasanthakumar (Victorian Heart Hospital)
Address
Country
Australia
Secondary sponsor category [1] 324737 0
None
Name [1] 324737 0
Address [1] 324737 0
Country [1] 324737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320416 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 320416 0
Ethics committee country [1] 320416 0
Australia
Date submitted for ethics approval [1] 320416 0
25/09/2025
Approval date [1] 320416 0
02/10/2025
Ethics approval number [1] 320416 0

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

Contacts
Principal investigator
Name 150414 0
A/Prof Nitesh Nerlekar
Address 150414 0
Victorian Heart Hospital, 631 black burn road, Clayton 3168, Victoria
Country 150414 0
Australia
Phone 150414 0
+61 417366511
Fax 150414 0
Email 150414 0
[email protected]
Contact person for public queries
Name 150415 0
Sheran Vasanthakumar
Address 150415 0
Victorian Heart Hospital, 631 black burn road, Clayton 3168, Victoria
Country 150415 0
Australia
Phone 150415 0
+61 03 7511 1111
Fax 150415 0
Email 150415 0
[email protected]
Contact person for scientific queries
Name 150416 0
Sheran Vasanthakumar
Address 150416 0
Victorian Heart Hospital, 631 black burn road, Clayton 3168, Victoria
Country 150416 0
Australia
Phone 150416 0
+61 03 7511 1111
Fax 150416 0
Email 150416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Data will be made available to suitably qualified researchers for the purposes of approved
collaborative research



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.