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临床试验/NCT01367769
NCT01367769终止不适用

Evaluation of Perivascular Venous Vascularization and Inflammation by Contrast-enhanced Ultrasound (CEUS) in Patients With Acute Deep Vein Thrombosis and Superficial Thrombophlebitis - a Pilot Study

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
20
试验地点
1
主要终点
Venous perivascular vascularization and inflammation

研究概览

简要总结

Background:

Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late phase CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. The inflammatory process of the vessel wall associated with perivascular angiogenesis at the time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may important in the development of post-thrombotic syndrome (PTS). Therefore the investigators will test the value of CEUS to detect venous perivascular vascularization and inflammation in patients with acute DVT or SVT.

Aims:

To determine the presence and degree of venous perivascular vascularization and inflammation assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without thrombosis.

Expected results:

The investigators hypothesize that venous perivascular vascularization and inflammation assessed by contrast agent enhancement can be quantified and will be significantly more pronounced in the perivascular tissue of the thrombotic vein than in the non affected vein and in controls, and will correlate with level of inflammatory markers and leg volume.

Significance:

These results would provide new information on the pathophysiological concept of thrombosis and thrombus resolution. It might help to better understand the pathophysiologic mechanisms that promote the development of chronic venous insufficiency and PTS.

详细描述

Background:

Contrast-enhanced ultrasound (CEUS) provides direct in-vivo visualization of the adventitial vasa vasorum using the fact that contrast agents microspheres are ideal intravascular tracers, thus, permitting a non-invasive assessment of the dynamic spatial and temporal heterogeneity of the microvasculature. Moreover, late phase CEUS has shown to detect inflammation by visualizing untargeted microbubbles phagocytosed by monocytes. The inflammatory process of the vessel wall and surrounding tissue associated with perivascular angiogenesis at the time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may promote destruction of venous valves, valvular reflux and subsequent development of post-thrombotic syndrome (PTS). Therefore, in this study, the investigators will test the value of CEUS to detect venous perivascular vascularization and inflammation in patients with acute DVT or SVT.

Aims:

To determine the presence and degree of venous perivascular vascularization and inflammation assessed with CEUS in patients with acute DVT or SVT, and compare this to controls without thrombosis.

Patients and Methods:

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Age greater than 18 years
  • acute, idiopathic or provoked, unilateral proximal DVT (involving the popliteal vein or further proximal veins)
  • SVT (more than 5cm in length on compression ultrasonography) of the lower- extremity
  • Age and sex matched controls will be recruited from volunteers after exclusion of DVT or SVT, and without history of thrombosis and pulmonary embolism

排除标准

  • History of previous DVT or SVT of the lower-extremity
  • History of pulmonary embolism
  • Bilateral DVT or SVT
  • DVT associated with intravenous drug abuse, surgery of the lower-extremity in the previous 10 days, or sclerotherapy in the previous 30 days
  • Follow-up is not considered feasible
  • Heart failure (HYHA III or IV)
  • Acute coronary syndrome (<7d)
  • Severe pulmonal-arterial hypertension (pulmonal arterial pressure >90mmHg)
  • Pregnancy

结局指标

主要结局

Venous perivascular vascularization and inflammation

时间窗: At baseline, 2 weeks, and 3 months

Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound

次要结局

  • Edema of the lower extremity(At baselin, 2 weeks, and 3 months)
  • Inflammatory markers(At baseline, 2 weeks, and 3 months)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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