Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Coronary Calcium Score
研究概览
简要总结
The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.
Is there a superiority of PWV compared to SCC:
详细描述
Two method of cardiovascular risk screening are compared in patient going for Coronary Calcium Score measurement in a outpatient clinic. Ct Scann is expensive, learning time is for at least 2 years, and the reliability is operator dependent.
The Pulse Wave Velocity is measured using a new device with half an hour learning curve, and you get a result within 2 minutes.
- A non-invasive medical device vs invasive
- A better benefit-risk ratio
- A lower diagnostic cost both for equipment and for qualification for use and learning time
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged over 18
- •Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
- •Subject affiliated to a social security scheme or beneficiary of such a scheme
- •Lack of participation in another clinical study
排除标准
- •Minor patient
- •Patient with obliterating arterial disease of the lower limbs
- •Patient with Sore fingers and hands
- •Patient with arrhythmia that does not allow measurement of VOP
- •Patient with limb amputation
- •Major subject protected by law, under curatorship or tutorship
结局指标
主要结局
Coronary Calcium Score
时间窗: 12 months
Coronary Calcium Score,
Pulse Wave Velocity
时间窗: 12 months
次要结局
未报告次要终点