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

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ClinicalTrials.gov Identifier: NCT01367769
Recruitment Status : Terminated (insufficient recruitment)
First Posted : June 7, 2011
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment
Thrombosis Other: No intervention

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Venous perivascular vascularization and inflammation [ Time Frame: At baseline, 2 weeks, and 3 months ]
    Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound


Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: At baseline, 2 weeks, and 3 months ]
    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)

  2. Edema of the lower extremity [ Time Frame: At baselin, 2 weeks, and 3 months ]
    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).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367769


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Daniel Staub, MD Unversity Hospital, Basel, Switzerland

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01367769     History of Changes
Other Study ID Numbers: DMS2154
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

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

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