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Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging

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ClinicalTrials.gov Identifier: NCT00677846
Recruitment Status : Unknown
Verified May 2008 by University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : May 15, 2008
Last Update Posted : May 15, 2008
Sponsor:
Information provided by:
University Hospital Freiburg

Brief Summary:

Background:

During the repair process of deep venous thrombosis, capillary formation is seen from day 18 to day 25. Contrast agent investigation is well known to detect small vessels in arterial disease. We intend to use this method to detect early vascularisation in the thrombus, in order to get more information about the evolution of the thrombosis in vivo.

Aims of the study:

Investigation of a newly diagnosed occluding venous thrombus with duplexsonography, using contrast agent and compare the degree of vascularization in the same patient after 3 weeks and 3 months. The relative signal intensity difference (baseline to peak) of the time intensity curve (TIC) is measured in defined region of interests (ROI). Comparison of the visibility of revascularisation between color duplexsonography, power mode and contrast agent will be done.

Method:

Patients with venous thrombosis of the proximal limb veins (femoral or popliteal vein) will be investigated with ultrasound agent in supine position. 5 ml of the contrast agent sulfur hexafluoride is given intravenously into a vein of the dorsal foot. The measurements are done in a defined area, where the thrombus is fully occluding in color Doppler investigation. The regions of interest will be the vessel walls and the centre of the thrombus in cross section view. The signal intensities are measured at baseline and peak (in decibel) in the centre and in the peripheral part of the vein. 20 patients with acute deep venous thrombosis will be included in this pilot study and investigated at baseline, after 3 weeks and 3 months.

Previously (before contrast agent application), the veins are investigated with color - and power Doppler to test visibility in comparison to the contrast agent investigation.


Condition or disease
Deep Venous Thrombosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging, a Follow up Study
Study Start Date : April 2007
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : August 2008

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Group/Cohort
3
Patients with symptoms of deep venous thrombosis less than for 2 weeks, with thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)



Primary Outcome Measures :
  1. Vascularisation in thrombosis in patients with initially occluded veins, assessed with ultrasound contrast agent (relative difference between baseline and peak of the time intensity curve) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a newly diagnosed occluding venous thrombus with duplexsonography and symptoms of deep venous thrombosis less than for 2 weeks.
Criteria

Inclusion Criteria:

  • Age > 18 and < 80 years old
  • Given written informed consent
  • Patients with symptoms of deep venous thrombosis less than for 2 weeks Thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)

Exclusion Criteria:

  • Arterial occlusive disease
  • Acute myocardial infarction, symptoms of coronary artery disease
  • Pregnancy
  • History of stroke or transient ischemic attack
  • Arterial hypertension uncontrolled
  • Allergy to contrast media
  • Participation in another study
  • Right heart insufficiency (clinical assessment with jugular vein filling in 45° sitting position)

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): NCT00677846


Locations
Germany
University of Freiburg Recruiting
Freiburg, Baden Würtemberg, Germany, 79110
Contact: Christina R. Jeanneret-Gris, MD    41-61-436-2060 ext 2780    christina.jeanneret@ksbh.ch   
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Christina R. Jeanneret-Gris, MD University of Freiburg

Responsible Party: Prof. Dr. C. Hehrlein, Abteilung Innere Medizin III, Kardiologie u. Angiologie
ClinicalTrials.gov Identifier: NCT00677846     History of Changes
Other Study ID Numbers: 314/03
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by University Hospital Freiburg:
contrast agent ultrasound, vein thrombosis, vascularization

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases