ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001738819

Ethics application status

Approved

Date submitted

22/10/2021

Date registered

20/12/2021

Date last updated

16/01/2023

Date data sharing statement initially provided

20/12/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

A multicentre randomised controlled trial evaluating whether a computed tomography calcium score in women with non-traditional cardiovascular risk factors can detect premature atherosclerosis and be used to improve cardiovascular risk factor control

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

CAC-Women Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cardiovascular disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

Health promotion/education

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Following consent and enrolment. women will attend for the baseline assessment and be sent for fasting pathology. Cardiovascular risk using current Australian risk calculator ((http://www.cvdcheck.org.au) will be calculated. Computed tomography (CT) Coronary artery calcium (CAC) will be performed. Once all results are obtained. participants are randomised to either intervention or control group.
In the intervention arm. 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, telehealth-delivered (or in person depending on participant preference), Cardiovascular Disease (CVD) risk factor counselling session. The study nurse/coordinator will be trained in the need for consistency in counselling and provided with a risk factor management package (printed and electronic information) containing standardised recommendations consistent with current guidelines, on how to improve CVD risk profiles. The risk factor counselling session (approximately 45min) will be aided by the use of the CT¬ CAC result. The CT-CAC report will be discussed, including the calcium score, age and sex-matched percentiles, and visual images of the participant's coronary arteries will be shown. All patients will have diet and exercise discussed, while those who are smokers, diabetic etc will have further discussions.
The result of the CT-CAC scan would be expected within a few days of the scan, and the counselling session will be scheduled to take place within 1 week of the scan being performed. Patients will receive a follow up telehealth counselling session by the study nurse at 1 and 3 months (10-20 minutes for each follow up), to monitor risk factor modification. Patients will be encouraged to follow up with their general practitioner (GP) to discuss their risk factors with a letter provided to the participant to take to their GP.

The risk factor management package has been based on the most recent guidelines for primary prevention of cardiovascular disease – the European Society of Cardiology (ESC) 2021 guidelines: https://pubmed.ncbi.nlm.nih.gov/34458905/ as well as the Cardiac Society guidelines on use of coronary artery calcium scoring to guide preventative therapy (https://www.csanz.edu.au/wp-content/uploads/2017/07/CAC_Position-Statement_2017_ratified-26-May-2017.pdf ) As well as clinical trial evidence for management of risk factors by the principle investigators.
The number of attended and missed sessions will be recorded for each participant to measure adherence to the risk factor counselling intervention. In addition, adherence to the risk factor modification is already being recorded through the lifestyle questionaires on diet, exercise and smoking administered at baseline and follow up.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Drugs

Comparator / control treatment

In the control group women remain under the care of their primary care physician and are blinded to the CAC result for the 6-month 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 current national recommendations/guidelines. Following the 6-month trial period, the patient and their GP will be provided with the written CAC report and the opportunity provided to discuss the result with the study nurse/coordinator at each site via telephone.

In the control group women remain under the care of their primary care physician and are blinded to the CAC result for the 6-month 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 current national recommendations/guidelines.
We do not wish to direct the care of the control group (it will be ‘standard care’ In this group), we will not be recommending certain guidelines.

Following the 6-month trial period, the patient and their GP will be provided with the written CAC report and the opportunity provided to discuss the result with the study nurse/coordinator at each site via telephone. 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.

Control group

Active

Outcomes

Primary outcome [1]

Mean Systolic blood pressure (mmHg)

Timepoint [1]

Outcome will be measured by spymomanometer at baseline and 6 months

Primary outcome [2]

Mean serum LDL-C (mmol/L)

Timepoint [2]

Outcome will be measured using a fasting blood sample at baseline and 6 months

Secondary outcome [1]

Mean diastolic blood pressure (BP)

Timepoint [1]

Diastolic BP will be measured by spymomanometer at baseline and 6 months

Secondary outcome [2]

HDL cholesterol (HDL-C)

Timepoint [2]

HDL-C will be measured via blood sample at baseline and 6 months

Secondary outcome [3]

Triglyceride (TG) levels

Timepoint [3]

TG will be measured via blood sample at baseline and 6 months

Secondary outcome [4]

HBA1C levels

Timepoint [4]

HBA1C will be measured via blood sample at baseline and 6 months

Secondary outcome [5]

Body mass index (BMI)

Timepoint [5]

BMI measured via calculation of height and weight using office scales at baseline and 6 months

Secondary outcome [6]

Waist circumference

Timepoint [6]

Waist circumference measured by study coordinators with a tape measure at baseline and 6 months

Secondary outcome [7]

Incidence of premature coronary artery disease as assessed by CT-CAC in low- intermediate risk women with risk-enhancing factors

Timepoint [7]

Measured by: CT coronary artery calcium scoring at baseline

Secondary outcome [8]

Change in women's healthy lifestyle behaviour (diet and physical activity)

Timepoint [8]

Measured by self-report on surveys at baseline and 6-months on levels of exercise and diet questionnaires specifically desinged for this study

Secondary outcome [9]

Total mortality and major adverse cardiovascular events will be analysed together as a composite outcome.

Timepoint [9]

Measured by data linkage at 5 and 10 years

Secondary outcome [10]

Change in women's awareness of their risk of CVD as a result of their specific obstetric complications

Timepoint [10]

Measured by self-report via a survey at baseline. Women's heart disease risk perception survey is desgined specially for this study.

Eligibility

Key inclusion criteria

1. Women able to give their informed consent will be eligible for inclusion if they are:
Criteria 1: Aged 40-65 years (35-65 years if Aboriginal and Torres Strait Islander)
Criteria 2: Low or intermediate risk for CVD based on traditional risk score (Australian absolute cardiovascular risk score between 3-15% inclusive)
Criteria 3: At least 1 risk-enhancing factor(s) (‘novel’ CVD risk factor) of:
a. Hypertensive disorder of pregnancy: gestational hypertension or pre-eclampsia and/or
b. Gestational diabetes and/or
c. Premature menopause (surgical/natural of age 44 years and less) and/or
d. Aboriginal and/or Torres Strait Islander background

Minimum age

35 Years

Maximum age

65 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

• Very low risk for CVD (3% or below) or high risk for CVD (>15%) based on an Australian Absolute cardiovascular disease risk calculator: https://www.cvdcheck.org.au
• Age 60 or over with diabetes mellitus (this automatically equates to risk score >15%)
• Pre-existing cardiovascular disease (cardiac, cerebrovascular or peripheral vascular disease)
• Known statin intolerance
• On dialysis (as this can affect calcium scoring)
• Currently pregnant or breastfeeding or plans for future pregnancies
• Limited life expectancy of more than 5 years or diagnosis with a terminal illness
• Unable to provide informed consent

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

randomisation using a computerised randomisation programme, which allocates 1:1 ratio ( intervention or control)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/07/2022

Actual

28/07/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

31/12/2034

Actual

Sample size

Target

700

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,NT,WA,VIC

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [3]

NT Cardiac - Tiwi

Recruitment hospital [4]

Menzies School of Health Research - Tiwi

Recruitment hospital [5]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [6]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [7]

The Alfred - Melbourne

Recruitment hospital [8]

Blacktown Hospital - Blacktown

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

6150 - Murdoch

Recruitment postcode(s) [3]

0810 - Tiwi

Recruitment postcode(s) [4]

3168 - Clayton

Recruitment postcode(s) [5]

3144 - Malvern

Recruitment postcode(s) [6]

2148 - Blacktown

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Foundation

Address [1]

Heart Foundation Sydney office
Level 3, 80 William Street
East Sydney NSW 2011
Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NSW Health

Address [2]

NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Australia

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
NSW 2006
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

western Sydney Local Health District

Ethics committee address [1]

WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2021

Approval date [1]

12/11/2021

Ethics approval number [1]

ETH11250

Summary

Brief summary

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 620 patients.  Asymptomatic women without CVD aged 45-65 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 and 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 undergo an in-person interview& examination

Trial website

Trial related presentations / publications

Public notes

The Coronary Artery Calcium Scoring in Women with Novel Cardiovascular Risk Factors Trial: The CAC-WOMEN Trial
Authors: Simone Marschner, Clara K Chow, Louise Maple-Brown, Edwina Wing-Lun, Stephen Nicholls, Alex Brown, John Mooney, Sian Graham, Amy Von Ruben, Dr. Abdul Ihdayhid, Sarah Zaman 

Corresponding author: A/Prof Sarah Zaman
The University of Sydney
Westmead Applied Research Centre, Faculty of Medicine and Health
Westmead Hospital, Westmead, NSW, 2145, Australia
T +61 2 8890 3125, 8890 6511, 8890 5555  and F +61 2 8890 8323 
Email: sarah.zaman@sydney.edu.au

Contacts

Principal investigator

Name

A/Prof Sarah Zaman

Address

Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145

Country

Australia

Phone

+61 414365523

Fax

sarah.zaman@sydney.edu.au

Contact person for public queries

Name

Swetha Perera

Address

Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145

Country

Australia

Phone

+61 433510318

Fax

swetha.perera@sydney.edu.au

Contact person for scientific queries

Name

Swetha Perera

Address

Westmead Applied Research Centre,
Level 6, Block K, Entrance 10, Westmead Hospital,
Hawkesbury Road, Westmead, NSW, 2145

Country

Australia

Phone

+61 433510318

Fax

swetha.perera@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Data can be obtained by contacting the primary investigator (A/Prof. sarah zaman), with any reasonable requests for the purpose of research considered.

When will data be available (start and end dates)?

Analysis will be performed at the end of the study Dec 2024. Data will be available until Dec 2039 ( 15years from end of study).

Available to whom?

Published in medical journals and and the main findings disseminated to participants who enrolled in the study.

Available for what types of analyses?

Statistical analyses through REDCAP database.

How or where can data be obtained?

Published in medical journals

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

Source	Title	Year of Publication	DOI
Embase	Randomised clinical trial using Coronary Artery Calcium Scoring in Australian Women with Novel Cardiovascular Risk Factors (CAC-WOMEN Trial): Study protocol.	2022	https://dx.doi.org/10.1136/bmjopen-2022-062685

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically