The Coronary Artery Calcium Scoring in Women with Novel Cardiovascular Risk Factors Trial (CAC-Women Trial)

None listed

Cardiovascular disease is the number one killer of Australian women. Yet CVD is preventable with early initiation of the right lifestyle and medical interventions. Current primary prevention relies on 'traditional' risk prediction tools. But almost all women under 65 are categorised as low risk, the vast majority of women who have coronary events are not identified, and novel, female-specific risk factors (e.g pre­ eclampsia, hypertensive disorders of pregnancy, gestational diabetes or premature menopause) are not considered. On top of this, women receive less primary prevention medical therapy, compared to men. These issues are even more pronounced in Aboriginal and Torres Strait Islander women (hereafter respectfully referred to as Aboriginal women). who have a larger burden of female-specific risk factors, and are even less likely to receive appropriate primary prevention. The CAC-Women's Trial aims to use a calcium score, measured via a simple, quick and widely available CT scan, to prompt lifestyle changes and medication use in women who are low-intermediate risk but have female-specific, risk-enhancing factors. in a randomised controlled trial (RCT) will evaluate the overall potential, feasibility and acceptability of a CAC-guided approach to primary prevention of CVD in women, and its impact on cardiovascular risk factor control. The CAC-WOMEN Trial will be a multi-site, randomised controlled trial assessing the effectiveness of a CAC-guided primary prevention intervention on cardiovascular risk factor control and healthy lifestyle adherence compared to usual care. The study aims to recruit 522 patients. Asymptomatic women without CVD aged 40-65 years (35-65 years for Aboriginal and Torres Strait Islander women) will be recruited from the community. Women will undergo blinded CT calcium scoring followed by 1:1 randomisation to intervention (CAC-guided care) or control (standard care). In the intervention group, women undergo a risk factor counselling session. This is performed by the study nurse/coordinator (and/or Aboriginal healthcare worker, where appropriate) with a private, one-on-one, CVD risk factor counselling session. The Study nurse/coordinator will provide printed and electronic information containing standardised recommendations consistent with current guidelines, on how to improve CVD risk profiles. The risk factor counselling session will be aided by the use of the CT-CAC result. Patients will receive a follow up telephone call by the study nurse at 1, 3 months, to monitor risk factor modification. In the control group women remain under the care of their primary care physician and are blinded to the CAC result for the 6month period. The participant is provided with a letter detailing the results of the baseline examination and pathology and are encouraged to see their GP for a discussion of risk factor treatment in accordance with standard care. All participants will be sent electronic survey follow up at 12m.