Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging
Recruitment status was Recruiting
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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 |
- 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 |
Patients with a newly diagnosed occluding venous thrombus with duplexsonography and symptoms of deep venous thrombosis less than for 2 weeks.
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| 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 | |
| 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 May 23, 2013