Thrombosis Clinical Trial
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
Verified date | April 2017 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | March 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Owen DR, Shalhoub J, Miller S, Gauthier T, Doryforou O, Davies AH, Leen EL. Inflammation within carotid atherosclerotic plaque: assessment with late-phase contrast-enhanced US. Radiology. 2010 May;255(2):638-44. doi: 10.1148/radiol.10091365. — View Citation
Staub D, Partovi S, Schinkel AF, Coll B, Uthoff H, Aschwanden M, Jaeger KA, Feinstein SB. Correlation of carotid artery atherosclerotic lesion echogenicity and severity at standard US with intraplaque neovascularization detected at contrast-enhanced US. Radiology. 2011 Feb;258(2):618-26. doi: 10.1148/radiol.10101008. Epub 2010 Oct 22. — View Citation
Staub D, Patel MB, Tibrewala A, Ludden D, Johnson M, Espinosa P, Coll B, Jaeger KA, Feinstein SB. Vasa vasorum and plaque neovascularization on contrast-enhanced carotid ultrasound imaging correlates with cardiovascular disease and past cardiovascular events. Stroke. 2010 Jan;41(1):41-7. doi: 10.1161/STROKEAHA.109.560342. Epub 2009 Nov 12. — View Citation
Staub D, Schinkel AF, Coll B, Coli S, van der Steen AF, Reed JD, Krueger C, Thomenius KE, Adam D, Sijbrands EJ, ten Cate FJ, Feinstein SB. Contrast-enhanced ultrasound imaging of the vasa vasorum: from early atherosclerosis to the identification of unstable plaques. JACC Cardiovasc Imaging. 2010 Jul;3(7):761-71. doi: 10.1016/j.jcmg.2010.02.007. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Venous perivascular vascularization and inflammation | Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound | At baseline, 2 weeks, and 3 months | |
Secondary | Inflammatory markers | 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 baseline, 2 weeks, and 3 months | |
Secondary | Edema of the lower extremity | Quantitative volume measurement of the legs will be performed using an automated 3D image measurement system (Bauerfeind®, Zeulenroda-Triebes, Germany). | At baselin, 2 weeks, and 3 months |
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