Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis
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.
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.
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.
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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|
- Venous perivascular vascularization and inflammation [ Time Frame: At baseline, 2 weeks, and 3 months ] [ Designated as safety issue: No ]Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
- Inflammatory markers [ Time Frame: At baseline, 2 weeks, and 3 months ] [ Designated as safety issue: No ]Interleukin-6 (IL-6), interleukin-8 (IL-8), monocyte chemoattractant-1 (MCP-1), Vascular cellular adhesion molecule-1 (VCAM-1), von Willebrand factor (vWF) and C-reactive protein (CRP)
- Edema of the lower extremity [ Time Frame: At baselin, 2 weeks, and 3 months ] [ Designated as safety issue: No ]Quantitative volume measurement of the legs will be performed using an automated 3D image measurement system (Bauerfeind®, Zeulenroda-Triebes, Germany).
Biospecimen Retention: Samples Without DNA
The investigators will also determine level of inflammatory markers as the cytokines interleukin-6 (IL-6), interleukin-8 (IL-8), monocyte chemoattractant-1 (MCP-1), Vascular cellular adhesion molecule-1 (VCAM-1), von Willebrand factor (vWF) and C-reactive protein (CRP) at each visit (baseline, 2 weeks, and 3 months).
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Patients with acute, idiopathic or provoked, unilateral proximal DVT (involving the popliteal vein or further proximal veins) and SVT of the lower-extremity detected with duplex ultrasound.
Age and sex matched controls (volunteers)
Other: No intervention
There will be no intervention in this study.
Other Name: No intervention
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01367769
|Contact: Daniel Staub, MD||61 328 6152 ext ++email@example.com|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4031|
|Contact: Daniel Staub, MD 61 328 6152 ext ++41 firstname.lastname@example.org|
|Principal Investigator: Daniel Staub, MD|
|Principal Investigator:||Daniel Staub, MD||Unversity Hospital, Basel, Switzerland|