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

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

Sponsors

Lead sponsor: University Hospital, Grenoble

Source University Hospital, Grenoble
Brief Summary

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

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

Overall Status Recruiting
Start Date January 2017
Completion Date February 2019
Primary Completion Date February 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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
Measure 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
Enrollment 30
Condition
Intervention

Intervention type: Radiation

Intervention name: elastography SWIRE

Arm group label: Diagnosis of deep vein thrombosis

Other name: Supersonic Imagine

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gilles PERNOD Principal Investigator University Hospital, Grenoble
Overall Contact

Last name: Gilles PERNOD

Phone: 00 334 767 657 17

Email: [email protected]

Location
facility status contact University Hospital Grenoble Gilles Pernod
Location Countries

France

Verification Date

January 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Diagnosis of deep vein thrombosis

Arm group type: Experimental

Description: All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.

Acronym ClotStruct
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov