Thrombosis Clinical Trial
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.
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.
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.
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