ACTRN12621001738819招募中未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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