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

Not Applicable

Recruiting

• Conditions: cardiovascular disease; Cardiovascular - Coronary heart disease; Public Health - Health promotion/education; Public Health - Epidemiology

• Registration Number: ACTRN12621001738819
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 700

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Systolic blood pressure (mmHg) [Outcome will be measured by spymomanometer at baseline and 6 months];Mean serum LDL-C (mmol/L)[Outcome will be measured using a fasting blood sample at baseline and 6 months]