Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging, a Follow up Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Vascularisation in thrombosis in patients with initially occluded veins, assessed with ultrasound contrast agent (relative difference between baseline and peak of the time intensity curve)
研究概览
简要总结
Background:
During the repair process of deep venous thrombosis, capillary formation is seen from day 18 to day 25. Contrast agent investigation is well known to detect small vessels in arterial disease. We intend to use this method to detect early vascularisation in the thrombus, in order to get more information about the evolution of the thrombosis in vivo.
Aims of the study:
Investigation of a newly diagnosed occluding venous thrombus with duplexsonography, using contrast agent and compare the degree of vascularization in the same patient after 3 weeks and 3 months. The relative signal intensity difference (baseline to peak) of the time intensity curve (TIC) is measured in defined region of interests (ROI). Comparison of the visibility of revascularisation between color duplexsonography, power mode and contrast agent will be done.
Method:
Patients with venous thrombosis of the proximal limb veins (femoral or popliteal vein) will be investigated with ultrasound agent in supine position. 5 ml of the contrast agent sulfur hexafluoride is given intravenously into a vein of the dorsal foot. The measurements are done in a defined area, where the thrombus is fully occluding in color Doppler investigation. The regions of interest will be the vessel walls and the centre of the thrombus in cross section view. The signal intensities are measured at baseline and peak (in decibel) in the centre and in the peripheral part of the vein. 20 patients with acute deep venous thrombosis will be included in this pilot study and investigated at baseline, after 3 weeks and 3 months.
Previously (before contrast agent application), the veins are investigated with color - and power Doppler to test visibility in comparison to the contrast agent investigation.
详细描述
- Study set up and Study design
It will be an open, non-randomized prospective clinical pilot study to assess the value of contrast agents in venous thrombus investigations.
a. Hypothesis
- The relative signal intensity increase in decibel after intravenous contrast media injection as a tool to measure thrombus - revascularization, assessed in defined regions of interests in the thrombus is smaller in acute occluding (< 2 week) thrombosis compared to the follow up measurements after 3 months in the same patient.
- Visibility of revascularization is increased with contrast agent compared to color Doppler - and power Doppler investigation assessed by 2 independent investigators
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Methods
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Clinical investigation
All patients and subjects will be investigated clinically. The patient's family history as well as the present and past history for deep venous thrombosis is assessed. The first day of symptoms of the deep vein thrombosis is noted. The thromboembolic disease is assessed clinically using the Wells' score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 and < 80 years old
- •Given written informed consent
- •Patients with symptoms of deep venous thrombosis less than for 2 weeks Thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)
排除标准
- •Arterial occlusive disease
- •Acute myocardial infarction, symptoms of coronary artery disease
- •Pregnancy
- •History of stroke or transient ischemic attack
- •Arterial hypertension uncontrolled
- •Allergy to contrast media
- •Participation in another study
- •Right heart insufficiency (clinical assessment with jugular vein filling in 45° sitting position)
结局指标
主要结局
Vascularisation in thrombosis in patients with initially occluded veins, assessed with ultrasound contrast agent (relative difference between baseline and peak of the time intensity curve)
时间窗: 3 months
次要结局
未报告次要终点