Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis

NCT01367769 | Terminated

• 1 other identifier: DMS2154
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombosis

Keywords

Deep vein thrombosis; superficial thrombophlebitis; contrast ultrasound

Outcome Measures

Primary Outcomes (1)

• Venous perivascular vascularization and inflammation

  Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound

  At baseline, 2 weeks, and 3 months

Secondary Outcomes (2)

• Inflammatory markers

  At baseline, 2 weeks, and 3 months

• Edema of the lower extremity

  At baselin, 2 weeks, and 3 months

Study Arms (1)

Thrombosis

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

Interventions

No intervention OTHER

There will be no intervention in this study.

Thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 patients with unilateral proximal DVT and 10 patients with SVT of the lower-extremity will be included in this study. As control, 10 volunteers without DVT or SVT, and without history of thromboembolism, will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 20971776 BACKGROUND

• 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.

  PMID: 20633855 BACKGROUND

• 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.

  PMID: 19910551 BACKGROUND

• 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.

  PMID: 20413774 BACKGROUND

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).

MeSH Terms

Conditions

Thrombosis; Venous Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Staub, MD

  Unversity Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 7, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CH (1)