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Can coronary artery calcium (CAC) score be calculated on radiotherapy planning computed tomography (CT) scans? (RO-CARDIAC)

Can coronary artery calcium (CAC) score identified on thoracic planning computed tomography (CT) scans be used and actioned to identify patients at high risk of cardiac events: a feasibility study in patients with cancer undergoing radiotherapy (RO-CARDIAC)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001343897
Acronym
RO-CARDIAC
Enrollment
101
Registered
2021-10-07
Start date
2022-08-10
Completion date
2023-05-31
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This study aims to assess whether a test called coronary artery calcium (CAC) score, can help predict the risk of a heart attack in cancer patients who are undergoing radiation therapy. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with any type of cancer, and you will be undergoing a thoracic computed tomography (CT) scan to plan for radiotherapy as part of your cancer treatment. Study details All participants who choose to enrol in this study will undergo their thoracic (chest) CT scan as planned, but the scan images will be used to calculate the CAC score will be completed after the scan. There are no changes to your normal scan for us to measure CAC. The duration of scan will be as per normal and you will not need any additional procedures. The CAC score will be used to identify patients who are at high risk of a heart attack in the future, and we will provide these patients with a referral to see the cardiologist (heart doctor) for management to help reduce this risk. After the scan you will have your radiotherapy treatment as planned. Throughout the study, you will be asked to complete a a series of questionnaires about your overall quality of life and your anxiety levels. You will be asked to complete these at the beginning of the study (Baseline), when you receive your CAC score from your doctor and about 3 months after you finish your radiotherapy treatment. It is hoped this research will demonstrate that the CAC score is able to identify patients who are at high risk of a heart attack in the future and help plan additional care to reduce this risk. We believe that this will have a positive effect on quality of life and reduce anxiety for future cancer patients undergoing radiotherapy.

Interventions

Main Study The study is investigating whether coronary artery calcium (CAC) score can be measured on thoracic radiotherapy planning computed tomography (CT) scan. It is the first prospective study in which this will be investigated. Patients who are ineligible or choose not to enrol in the study will not have CAC scored. They will be counselled on cardiac risk by their treating doctor and if indicated referred to a cardiologist as standard processes. CAC scoring will not involve any additional

Main Study The study is investigating whether coronary artery calcium (CAC) score can be measured on thoracic radiotherapy planning computed tomography (CT) scan. It is the first prospective study in which this will be investigated. Patients who are ineligible or choose not to enrol in the study will not have CAC scored. They will be counselled on cardiac risk by their treating doctor and if indicated referred to a cardiologist as standard processes. CAC scoring will not involve any additional procedure (including dye or tracer) or time for study participants above their standard radiotherapy planning CT which is completed as part of their normal care. Following the scan, the CT images will be provided to a central cardiologist who will measure the patient's CAC score. Following receipt of the CAC score, patients that are identified as high risk, defined as those with a CAC score of >0, will be referred to a CardioOncology clinic. When the CAC score is received, the participant's doctor will discuss the result with them and provide this referral. Following referral, participants will then be managed by the cardiologist as clinically required per normal cardiology practice. Participants will also continue with radiotherapy as per normal with their radiation oncologist. Participants with a CAC score of 0 are not considered high risk, and will therefore not be referred to the CardioOncology clinic. They will be managed by their treating radiation oncologist as per normal. Feasibility as defined by adherence to the recommended pathway and impact on patient quality of life will be observed. Participants will be asked to complete questionnaires assessing general quality of life, anxiety and patient experience at Baseline, following CAC scoring and approximately 3 months after completing their radiotherapy treatment. The research team will assess adherence to the treatment pathway by reviewing medical records for attendance at the 3 month follow-up. The duration of study participation for participants will be up to approximately 6 months, depending on the length of their radiotherapy treatment regimen Optional Sub-study (WA only) Patients who reside in WA will have the option to take part in an additional sub-study, coordinated by our colleagues at Edith Cowan University. Patients living outside of WA, or choose not to enrol in the sub-study will not have any procedures outlined in the sub-study completed. They will continue to take part in the main study. In addition to CAC measured in the coronary arteries, the abdominal aorta is another blood vessel in which calcium build up can be measured. The optional sub-study aims to measure abdominal aortic calcification (AAC) on Bone density scans (Dual-energy X-ray Absorptiometry, or DXA scans) to help identify patients who are at a higher risk of a heart attack in the future, as well as to measure bone density and body composition. Previous studies have measured AAC in the general population, but this study will be the first time AAC is being used to assess cardiovascular health in cancer patients. Risk of a future heart attack can be reduced by following dietary and physical activity guidelines. Therefore, the sub-study will also examine diet and physical activity behaviours. It will also assess the diet and physical activity support patients undergoing radiotherapy receive throughout their treatment. Patients that take part in the sub-study will have their weight and height measured, undergo four DXA scans to measure body composition and AAC, and complete two online questionnaires within 2 weeks of starting radiotherapy. These procedures are all completed specifically for the sub-study in addition to standard of care. DXA scan and AAC results will be provided to the patient’s GP who will discuss any abnormal results. Following completion of their radiotherapy, selected sub-study participants will complete an online interview with researchers to ask about their experiences receiving diet and physical activity support during treatment. All sub-study participants will complete a 12 month follow up visit after Baseline where the same study assessments will be completed again for comparison. The duration of study participation for all participants is therefore approximately 12 months.

Sponsors

GenesisCare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Age 18 years or older • Has provided written informed consent for participation • Histological or cytologically confirmed malignancy • Undergoing thoracic CT for radiotherapy planning • Receiving radiotherapy, with curative intent, as part of standard treatment for malignancy • Optional sub-study only: Resides in Western Australia

Exclusion criteria

• Pregnancy or lactation • Known coronary artery disease. • Currently under the care of a cardiologist • Life expectancy < 5 years • Any other factor which, in the opinion of the study investigator, would adversely impact on the patient’s ability to participate in the study safely and fully.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 15, 2026