breast cancer, cardiovascular disease, coronary artery calcification breast cancer, heart disease, calcium deposits in heart vessels
Conditions
Interventions
The intervention is the CVD risk estimation based on the CAC (Agatston) score using RT planning CT scans, 
 
and the subsequent disclosure of the 
estimated CVD risk and corresponding 
CVD risk-based management 
to the patient using the ARTILLERY manual. 
The CAC (Agatston) score will be measured after the RT planning CT scan is made, which is usually one or two weeks before the start of RT. 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients will be asked to provide written informed consent before patient start of the study, according to ICH/GCP/Declaration of Helsinki, and national/local regulations. To be eligible to participate in this study, all trial participants must meet the following criteria:Aged 35 years or overtreated for their primary breast cancer diagnosis with a curative intentPlanned for breast radiotherapy.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Psychological-, familial-, sociological- or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule;Unable to measure coronary artery calcifications on radiotherapy planning CT scans (e.g., metal implants, excessive noises, artifacts).Pregnant or breastfeeding individuals The age exclusion under 35 years reflects the very low proportion of such patients with coronary artery calcifications (Agatston) scores >0, for whom actionable information is highly unlikely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Agatston score is a validated method for CVD risk assessment using the amount of CAC. CVD risk is categorized in 5 groups with an Agatston score of 0, 1–10, 11–100, 101–400, and >400. In the current trial, endpoints will be analyzed according to low, moderate, and high-CVD-risk groups corresponding to score ranges 0-10, 11-100, and >100, respectively. The primary endpoints of this study are retrospective changes on breast cancer treatment (retrospective) and CVD risk-based management (cardiovascular care), as well as impacts on patients’ satisfaction with their decision to receive personalized CVD-risk estimation and CVD risk-based management/recommendation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are patients’ decisions regarding their lifestyle and habits, patients’ decisional conflict regarding lifestyle decision changes, QoL, and , PRO’s including anxiety, changes in CVD risk factors and CVD treatment (e.g., use of aspirins and statins). The study will assess impacts on primary and secondary endpoints at multiple timepoints. | — |
Countries
Denmark, Germany, Netherlands, Portugal
Contacts
Public ContactH.M. Verkooijen
Universitair Medisch Centrum Utrecht
Outcome results
None listed