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

Deep Vein Thrombosis Clinical Trial

— ClotStruct  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02859532
• Other study ID #: 38RC15.355
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: January 2019
• Source: University Hospital, Grenoble
• Contact: Gilles PERNOD
• Phone: 00 334 767 657 17
• Email: GPernod[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Radiation:
• elastography SWIRE

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated		Day 0, Day 7, Day 30
Secondary	Thrombus properties if provoked versus unprovoked thrombosis		Day 0, Day 7, Day 30
Secondary	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