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

This study is currently recruiting participants.
Verified October 2012 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01367769
First received: June 3, 2011
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Thrombosis
 Other: No intervention

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
There will be no intervention in this study.
Other Name: No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367769

Contacts
Contact: Daniel Staub, MD 61 328 6152 ext ++41 staubd@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Daniel Staub, MD     61 328 6152 ext ++41     staubd@uhbs.ch    
Principal Investigator: Daniel Staub, MD            
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Staub, MD Unversity Hospital, Basel, Switzerland
  More Information

Publications:

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01367769     History of Changes
Other Study ID Numbers: DMS2154
Study First Received: June 3, 2011
Last Updated: October 24, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Deep vein thrombosis
superficial thrombophlebitis
contrast ultrasound

Additional relevant MeSH terms:
Inflammation
Neovascularization, Pathologic
Thrombophlebitis
Thrombosis
Venous Thrombosis
Pathologic Processes
Metaplasia
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on May 19, 2013