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Venous Vascularization and Inflammation on Contrast-enhanced Ultrasound (CEUS) in Patients With Thrombosis

21. april 2017 opdateret af: University Hospital, Basel, Switzerland

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Basel, Schweiz, 4031
        • University Hospital Basel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Venous perivascular vascularization and inflammation
Tidsramme: At baseline, 2 weeks, and 3 months
Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
At baseline, 2 weeks, and 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inflammatory markers
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Daniel Staub, MD, Unversity Hospital, Basel, Switzerland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

3. juni 2011

Først indsendt, der opfyldte QC-kriterier

6. juni 2011

Først opslået (Skøn)

7. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2017

Sidst verificeret

1. april 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med No intervention

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