Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)

Study Overview
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Brief Summary
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Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration. Few data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected. Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.

Detailed Description
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The main objective of the study is to characterize the in vivo properties of elastographic thrombus in patients with proximal deep vein thrombosis (DVT), for quantitative elastography performed at D0, D7, D30. The ability to analyze the structural properties of the thrombus should allow us to then correlate these properties to the evolving nature of the thrombus (embolic migration or not, recanalization or not), and the effect of different treatment on the evolution of the thrombus

Official Title
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Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Radiation: elastography SWIRE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with proximal DVT, provoked or not, the symptomatology is less than 3d, with or without pulmonary embolism treated with heparin or oral anticoagulant Signed informed consent Patient affiliated to a social security scheme, Exclusion Criteria: pregnant or lactating Life expectancy <1 month Patient with distal DVT or asymptomatic DVT accidental discovery Patient who underwent venous unclogging in acute phase exclusion period in another study, under administrative or judicial oversight, under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnosis of deep vein thrombosis<br>All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test. | Radiation: elastography SWIRE<br> <br> * Other names: Supersonic Imagine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in in vivo elastographic properties of thrombus in patients with proximal deep vein thrombosis (DVT) through quantitative elastography |  | Day 0, Day 7, Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated |  | Day 0, Day 7, Day 30 | 
| Thrombus properties if provoked versus unprovoked thrombosis |  | Day 0, Day 7, Day 30 | 
| Correlation of the thrombus in vivo properties to the thrombin generation capacity and viscoelastic properties tested ex vivo by rotational thromboelastometry |  | Day 0, Day 7, Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood coagulation, Endogenous Thrombin Potential, rotational thromboelastometry