ThrombosisNCT01367769
Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis
An observational study of Thrombosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Background: Contrast-enhanced ultrasound (CEUS) visualization of the adventitial vasa vasorum. Late phase CEUS detect inflammation by visualizing microbubbles phagocytosed by monocytes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Acute coronary syndrome (<7d)
- Severe pulmonal-arterial hypertension (pulmonal arterial pressure >90mmHg)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
Background:
Contrast-enhanced ultrasound (CEUS) provides direct in-vivo visualization of the adventitial vasa vasorum using the fact that contrast agents microspheres are ideal intravascular tracers, thus, permitting a non-invasive assessment of the dynamic spatial and temporal heterogeneity of the microvasculature. Moreover, late phase CEUS has shown to detect inflammation by visualizing untargeted microbubbles phagocytosed by monocytes. The inflammatory process of the vessel wall and surrounding tissue associated with perivascular angiogenesis at the time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may promote destruction of venous valves, valvular reflux and subsequent development of post-thrombotic syndrome (PTS). Therefore, in this study, 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.
Patients and Methods:
20 patients with first 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. Diagnosis of DVT and SVT will be performed using standard compression and duplex ultrasound using a Philips (Bothel, WA) ultrasound scanner (iU22) equipped with a linear array L9-4 megahertz (MHz) probe. For CEUS imaging 2.5ml of SonoVueTM (Bracco spa, Milan, Italy) will be injected as an intravenous bolus into an antecubital vein. The thrombotic popliteal vein and the normal popliteal vein at the contralateral side or the thrombotic superficial vein and the normal superficial vein at the contralateral side will be evaluated using a standardized cross-sectional view. Similarly the normal popliteal vein and the superficial vein in a control group will be evaluated. Perivascular contrast-enhancement will be determined with visual interpretation (absent, moderate, abundant) and with quantitative analysis using a dedicated QLAB software (Philips; Bothel, WA) to quantify video intensity within the first minute after bolus contrast injection (perivascular vascularization) and at 6 minutes following the bolus contrast injection (inflammation). Visual based and quantitative analysis of perivascular contrast-enhancement in DVT or SVT will be compared to the contrast-enhancement at the non affected contralateral side and to results of the control group. CEUS imaging with quantification of perivascular contrast-enhancement will be performed at baseline, 2 weeks, and 3 months after acute thrombosis or initial investigation in controls. Additionally, at each visit, measurement of inflammatory markers (MCP-1, IL-6, IL-8, VCAM-1, vWF, and CRP), as well as quantitative measurement of leg volume using an automated 3D image system (Bauerfeind®, Zeulenroda-Triebes, Germany) will be performed.
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. Vascularization and inflammation will decrease during the process of thrombus resolution from baseline to 3 months follow-up.
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 post-thrombotic syndrome. As inflammation with pronounced perivascular vascularization might play an important role in incomplete thrombus clearance, venous outflow obstruction and the development of post-thrombotic syndrome after acute DVT, in the future, our results could lead to novel approaches to interrupt the natural history and prevent post-thrombotic syndrome.
- Conditions
- Thrombosis
- Being tested
- No intervention
- Keywords
- Deep vein thrombosis, superficial thrombophlebitis, contrast ultrasound
- Medical subject headings
- Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous perivascular vascularization and inflammation
Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
Measured: At baseline, 2 weeks, and 3 months
Secondary outcomes (2)
Inflammatory markers
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)
Measured: At baseline, 2 weeks, and 3 months
Edema of the lower extremity
Quantitative volume measurement of the legs will be performed using an automated 3D image measurement system (Bauerfeind®, Zeulenroda-Triebes, Germany).
Measured: At baselin, 2 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015
- Study completionMar 2017
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Staub, MD, Principal investigator, Unversity Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367769
- Sponsor's protocol ID
- DMS2154
- Status last verified
- Apr 2017
- First submitted
- 3 Jun 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Staub D, Partovi S, Schinkel AF, Coll B, Uthoff H, Aschwanden M, Jaeger KA, Feinstein SB. Correlation of carotid artery atherosclerotic lesion echogenicity and severity at standard US with intraplaque neovascularization detected at contrast-enhanced US. Radiology. 2011 Feb;258(2):618-26. doi: 10.1148/radiol.10101008. Epub 2010 Oct 22.
PubMed 20971776Staub D, Schinkel AF, Coll B, Coli S, van der Steen AF, Reed JD, Krueger C, Thomenius KE, Adam D, Sijbrands EJ, ten Cate FJ, Feinstein SB. Contrast-enhanced ultrasound imaging of the vasa vasorum: from early atherosclerosis to the identification of unstable plaques. JACC Cardiovasc Imaging. 2010 Jul;3(7):761-71. doi: 10.1016/j.jcmg.2010.02.007.
PubMed 20633855Staub D, Patel MB, Tibrewala A, Ludden D, Johnson M, Espinosa P, Coll B, Jaeger KA, Feinstein SB. Vasa vasorum and plaque neovascularization on contrast-enhanced carotid ultrasound imaging correlates with cardiovascular disease and past cardiovascular events. Stroke. 2010 Jan;41(1):41-7. doi: 10.1161/STROKEAHA.109.560342. Epub 2009 Nov 12.
PubMed 19910551Owen DR, Shalhoub J, Miller S, Gauthier T, Doryforou O, Davies AH, Leen EL. Inflammation within carotid atherosclerotic plaque: assessment with late-phase contrast-enhanced US. Radiology. 2010 May;255(2):638-44. doi: 10.1148/radiol.10091365.
PubMed 20413774
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01367769
- Acronym / sponsor ID
- DMS2154
- Conditions
- Thrombosis
- Keywords
- Deep vein thrombosis, superficial thrombophlebitis, contrast ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Contrast-enhanced ultrasound (CEUS) provides direct in-vivo visualization of the adventitial vasa vasorum using the fact that contrast agents microspheres are ideal intravascular tracers, thus, permitting a non-invasive assessment of the dynamic spatial and temporal heterogeneity of the microvasculature. Moreover, late phase CEUS has shown to detect inflammation by visualizing untargeted microbubbles phagocytosed by monocytes. The inflammatory process of the vessel wall and surrounding tissue associated with perivascular angiogenesis at the time of deep venous thrombosis (DVT) and superficial vein thrombophlebitis (SVT) may promote destruction of venous valves, valvular reflux and subsequent development of post-thrombotic syndrome (PTS). Therefore, in this study, 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.
Patients and Methods:
20 patients with first 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. Diagnosis of DVT and SVT will be performed using standard compression and duplex ultrasound using a Philips (Bothel, WA) ultrasound scanner (iU22) equipped with a linear array L9-4 megahertz (MHz) probe. For CEUS imaging 2.5ml of SonoVueTM (Bracco spa, Milan, Italy) will be injected as an intravenous bolus into an antecubital vein. The thrombotic popliteal vein and the normal popliteal vein at the contralateral side or the thrombotic superficial vein and the normal superficial vein at the contralateral side will be evaluated using a standardized cross-sectional view. Similarly the normal popliteal vein and the superficial vein in a control group will be evaluated. Perivascular contrast-enhancement will be determined with visual interpretation (absent, moderate, abundant) and with quantitative analysis using a dedicated QLAB software (Philips; Bothel, WA) to quantify video intensity within the first minute after bolus contrast injection (perivascular vascularization) and at 6 minutes following the bolus contrast injection (inflammation). Visual based and quantitative analysis of perivascular contrast-enhancement in DVT or SVT will be compared to the contrast-enhancement at the non affected contralateral side and to results of the control group. CEUS imaging with quantification of perivascular contrast-enhancement will be performed at baseline, 2 weeks, and 3 months after acute thrombosis or initial investigation in controls. Additionally, at each visit, measurement of inflammatory markers (MCP-1, IL-6, IL-8, VCAM-1, vWF, and CRP), as well as quantitative measurement of leg volume using an automated 3D image system (Bauerfeind®, Zeulenroda-Triebes, Germany) will be performed.
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. Vascularization and inflammation will decrease during the process of thrombus resolution from baseline to 3 months follow-up.
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 post-thrombotic syndrome. As inflammation with pronounced perivascular vascularization might play an important role in incomplete thrombus clearance, venous outflow obstruction and the development of post-thrombotic syndrome after acute DVT, in the future, our results could lead to novel approaches to interrupt the natural history and prevent post-thrombotic syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombosis | – | Other: No interventionPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere will be no intervention in this study. | Other | Thrombosis |
Primary outcome
Venous perivascular vascularization and inflammation
Time frame: At baseline, 2 weeks, and 3 months
Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
2 secondary outcomes
Inflammatory markers
Time frame: At baseline, 2 weeks, and 3 months
Edema of the lower extremity
Time frame: At baselin, 2 weeks, and 3 months
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Background: PubMed 20971776Staub D, Partovi S, Schinkel AF, Coll B, Uthoff H, Aschwanden M, Jaeger KA, Feinstein SB. Correlation of carotid artery atherosclerotic lesion echogenicity and severity at standard US with intraplaque neovascularization detected at contrast-enhanced US. Radiology. 2011 Feb;258(2):618-26. doi: 10.1148/radiol.10101008. Epub 2010 Oct 22.
- Background: PubMed 20633855Staub D, Schinkel AF, Coll B, Coli S, van der Steen AF, Reed JD, Krueger C, Thomenius KE, Adam D, Sijbrands EJ, ten Cate FJ, Feinstein SB. Contrast-enhanced ultrasound imaging of the vasa vasorum: from early atherosclerosis to the identification of unstable plaques. JACC Cardiovasc Imaging. 2010 Jul;3(7):761-71. doi: 10.1016/j.jcmg.2010.02.007.
- Background: PubMed 19910551Staub D, Patel MB, Tibrewala A, Ludden D, Johnson M, Espinosa P, Coll B, Jaeger KA, Feinstein SB. Vasa vasorum and plaque neovascularization on contrast-enhanced carotid ultrasound imaging correlates with cardiovascular disease and past cardiovascular events. Stroke. 2010 Jan;41(1):41-7. doi: 10.1161/STROKEAHA.109.560342. Epub 2009 Nov 12.
- Background: PubMed 20413774Owen DR, Shalhoub J, Miller S, Gauthier T, Doryforou O, Davies AH, Leen EL. Inflammation within carotid atherosclerotic plaque: assessment with late-phase contrast-enhanced US. Radiology. 2010 May;255(2):638-44. doi: 10.1148/radiol.10091365.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Staub, MD principal investigator
Unversity Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous perivascular vascularization and inflammation (time frame: At baseline, 2 weeks, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367769, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.