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

January 4, 2019 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • University Hospital Grenoble
        • Contact:
          • Gilles Pernod

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnosis of deep vein thrombosis
All subjects with proximal DVT will have quantitative elastography SWIRE, thrombin generation test and rotational thromboelastometry test.
Radiation: elastography SWIRE
Other Names:
  • Supersonic Imagine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Thrombus properties depending on the existence or absence of pulmonary embolism (PE) associated
Time Frame: Day 0, Day 7, Day 30
Day 0, Day 7, Day 30
Thrombus properties if provoked versus unprovoked thrombosis
Time Frame: Day 0, Day 7, Day 30
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
Time Frame: Day 0, Day 7, Day 30
Day 0, Day 7, Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gilles PERNOD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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