Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis
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.
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Basel、スイス、4031
- University Hospital Basel
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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) |
There will be no intervention in this study.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Venous perivascular vascularization and inflammation
時間枠:At baseline, 2 weeks, and 3 months
|
Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
|
At baseline, 2 weeks, and 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inflammatory markers
時間枠: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)
|
At baseline, 2 weeks, and 3 months
|
|
Edema of the lower extremity
時間枠: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).
|
At baselin, 2 weeks, and 3 months
|
協力者と研究者
捜査官
- 主任研究者:Daniel Staub, MD、Unversity Hospital, Basel, Switzerland
出版物と役立つリンク
一般刊行物
- Staub 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.
- Staub 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.
- 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.
- Owen 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。