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Clinical Trials/ACTRN12621001738819
ACTRN12621001738819
Recruiting
未知

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

The University of Sydney0 sites700 target enrollmentDecember 20, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
cardiovascular disease
Sponsor
The University of Sydney
Enrollment
700
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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