The Evaluation of Tomographic 3D Ultrasound for the Assessment of Vascular Pathology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Diameter reduction measurement
研究概览
简要总结
This study concentrates on providing more ultrasound image details when scanning vascular system including arterial and venous systems.
A new sensor which provides 3D images is newly designed. It will be used in this study to find out whether it can change the future of vascular imaging or not.
详细描述
Ultrasound is ideal for diagnosing vascular pathology due to its advantage of using different elements within its transducers, such as beam steering, focusing and high frame rate. It is also available and low costs when compared to other diagnostic modalities such as Computed Tomography (CT scan) and Magnetic Resonance Imaging (MRI). In addition to that, Duplex ultrasound (DUS) uses high sound waves with no ionising radiation. Therefore, it's fairly safe to the patient with long term surveillance.
DUS provides valuable information in diagnosing vascular disease due to its ability to detect flow motion within a vessel. It is, therefore, able to define whether the vessel being scanned is narrowed, diseased or blocked.
3D Ultrasound: 3D ultrasound provides images from different angles for better detection of structures being assessed. Therefore, the accuracy of the vessels and anatomical structures around is high. 3D Volume now becomes available and can be calculated and potentially benefits patients by detecting and defining those who are at risk of vascular disease.
There are three types of 3D ultrasound which are:
- Mechanical 3D
- 3D and 4D matrix scanning.
- Freehand 3D sensor. (Will be used in this project).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years age with vascular disease.
- •Male / Female.
排除标准
- •<18 years age.
- •Patient with congenital vascular abnormalities/syndromes.
- •Pregnant patients will not be recruited in this study. Patient's pregnancy status will be assessed on initial enrollment to exclude them from the study.
- •Those unable to provide consent.
- •Anyone who is taking part in any other research.
- •Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs.
结局指标
主要结局
Diameter reduction measurement
时间窗: 12 weeks
The ultrasound medicine does calculate the diameter reduction automatically when the operator places the calliper at the vessels wall.
Peck systolic velocity
时间窗: 12 weeks
Normal peck systolic velocity (PSV) is 125cm/s. More than 250 cm/s considered 50% stenosis .
Peck systolic ration
时间窗: 12 weeks
Normal peak systolic velocity rations less than 1.5 and more than 2 is considered 50% stenosis. This can be calculated by measuring the peak systolic velocity within the stenotic area divided by either pre or post stenotic area.
次要结局
- Plaque volume(12 weeks)
- Max area stenosis.(12 weeks)
- 3D GSM.(12 weeks)
- Volumetric stenosis.(12 weeks)
- Measured length.(12 weeks)