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

2017년 4월 21일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

20

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Basel, 스위스, 4031
        • University Hospital Basel

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Venous perivascular vascularization and inflammation
기간: At baseline, 2 weeks, and 3 months
Venous perivascular vascularization and inflammation assessed by contrast-enhanced ultrasound
At baseline, 2 weeks, and 3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Inflammatory markers
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Daniel Staub, MD, Unversity Hospital, Basel, Switzerland

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 3월 1일

기본 완료 (실제)

2015년 12월 1일

연구 완료 (실제)

2017년 3월 1일

연구 등록 날짜

최초 제출

2011년 6월 3일

QC 기준을 충족하는 최초 제출

2011년 6월 6일

처음 게시됨 (추정)

2011년 6월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 21일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • DMS2154

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