NCT00588484已完成不适用
Determination of the Precision and Clinical Utility of Ultrasound-based Intima-Media Thickness Measurements
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The primary statistical endpoint for this study is to determine the standard deviation and 95% confidence interval of IMT measurements obtained using our standard method.
研究概览
简要总结
Develop a standard technique and demonstrate adequate precision for measurement of intima-media thickness (IMT) for routine clinical use.
详细描述
IMT is measured using software to analyze ECG-gated US image sequences acquired using a standard protocol. Two sonographers acquire images and measure IMT for 100 vessels. IMT technique standard deviation (SD) is determined by assuming normally distributed measurements, and dividing the SD of the 100 (paired) IMT differences by sqrt(2). This SD will be taken as measures of precision of the IMT technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have an appointment at either the Cardiovascular Health Clinic or scheduled for a carotid ultrasound.
排除标准
- •Carotid endarterectomy,carotid stenting, carotid repair, less than 45 degree range of motion in the neck, and/or cannot lie flat on back.
- •Participants Enrolled who are found after imaging not to exhibit a ~1cm long common carotid far wall region free of focal plaque in which to measure IMT will not have their data analyzed further.
结局指标
主要结局
The primary statistical endpoint for this study is to determine the standard deviation and 95% confidence interval of IMT measurements obtained using our standard method.
时间窗: Four years
次要结局
- Standard deviation and 95% confidence interval of our IMT measurement method considering data subsets with variable US image quality levels, and different levels of image plane correlation.(Two years)
研究者
研究点 (1)
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