Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00677846
First received: May 13, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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
Deep Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging, a Follow up Study

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: April 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 13, 2008
Last Updated: May 13, 2008
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 28, 2014