Marschner S

Wing-Lun, Edwina

Chow C

Maple-Brown, Louise

Graham S

Nicholls SJ

Brown A

Wood, Anna

Ihdayhid A

Von Huben A

Zaman S

2022-12-22

INTRODUCTION: Cardiovascular disease (CVD) is the leading cause of death in women around the world. Aboriginal and Torres Strait Islander women (Australian Indigenous women) have a high burden of CVD, occurring on average 10-20 years earlier than non-Indigenous women. Traditional risk prediction tools (eg, Framingham) underpredict CVD risk in women and Indigenous people and do not consider female-specific 'risk-enhancers' such as hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM) and premature menopause. A CT coronary artery calcium score ('CT-calcium score') can detect calcified atherosclerotic plaque well before the onset of symptoms, being the single best predictor for future cardiac events. A CT-calcium score may therefore help physicians intensify medical therapy in women with risk-enhancing factors. METHODS AND ANALYSIS: This multisite, single-blind randomised (1:1) controlled trial of 700 women will assess the effectiveness of a CT-calcium score-guided approach on cardiovascular risk factor control and healthy lifestyle adherence, compared with standard care. Women without CVD aged 40-65 (35-65 for Aboriginal and Torres Strait Islander women) at low-intermediate risk on standard risk calculators and with at least one risk-enhancing factor (eg, HDP, GDM, premature menopause) will be recruited. Aboriginal and Torres Strait Islander women will be actively recruited, aiming for ~10% of the sample size. The 6-month coprimary outcomes will be low-density lipoprotein cholesterol and systolic blood pressure. Barriers and enablers will be assessed, and a health economic analysis performed. ETHICS AND DISSEMINATION: Western Sydney Local Health District Research Ethics Committee (HREC 2021/ETH11250) provided ethics approval. Written informed consent will be obtained before randomisation. Consent will be sought for access to individual participant Medicare Benefits Schedule, Pharmaceutical Benefits Scheme claims usage through Medicare Australia and linked Admitted Patient Data Collection. Study results will be disseminated via peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001738819p.

Westmead Applied Research Centre, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia simone.marschner@sydney.edu.au.

Westmead Applied Research Centre, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.

Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.

Department of Cardiology, Royal Darwin Hospital, Tiwi, Northern Territory, Australia.

Department of Cardiology, Westmead Hospital, Westmead, New South Wales, Australia.

Department of Endocrinology, Royal Darwin Hospital, Tiwi, Northern Territory, Australia.

Aboriginal and Torres Strait Islander Advisory Group, Diabetes across the Lifecourse: Northern Australia Partnership, Menzies School of Health Research, Tiwi, Northern Territory, Australia.

Monash Heart, Monash Health, Monash University, Clayton, Victoria, Australia.

Indigenous Genomics, Australian National University, Canberra, ACT, Australia.

Telethon Kids Institute, Perth Children's Hospital, Nedlands, WA, Australia.

Fiona Stanley Hospital, Harry Perkins Institute of Medical Research, Perth, Western Australia, Australia.

Menzies Centre for Health Policy and Economics, The University of Sydney, Sydney, New South Wales, Australia.

Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.

BMJ Open . 2022 Dec 22;12(12):e062685. doi: 10.1136/bmjopen-2022-062685.

https://pubmed.ncbi.nlm.nih.gov/36549726/?otool=iaurydwlib

https://hdl.handle.net/10137/12365

12

Pregnancy

Humans

Female

Aged

Risk Factors

*Cardiovascular Diseases

Calcium/therapeutic use

Single-Blind Method

Coronary Vessels

*Menopause, Premature

Native Hawaiian or Other Pacific Islander

Australia/epidemiology

National Health Programs

Heart Disease Risk Factors

Randomized Controlled Trials as Topic

Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): study protocol.

Journal Article

Publication