A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

Ultrasound Elastography: a New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT).

Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. One potential technique to age DVT is ultrasound elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well known that thrombi harden as they age. The aim of this study will be to assess the ability of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique. The demographic data, medical history, physical examination and the results of CUS and ultrasound elastography will be collected in a case report form (CRF) by another investigator who does not perform the examinations. The blinded CRF will be submitted to a dedicated committee for statistical analysis.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Elastography; Elasticity Imaging Techniques; Compression Ultrasound
• Intervention / Treatment: Other: ultrasound elastography

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Livorno, Tuscany, Italy, 57100
      • Azienda USL 6 Livorno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In this study, we will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique.

Description

Inclusion Criteria:

• acute first episode of unprovoked DVT of lower limbs
• chronic first episode of unprovoked DVT of lower limbs (at third month of follow up)

Exclusion Criteria:

• previous episodes of DVT
• ongoing anticoagulation
• age younger than 18 years
• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DVT of the lower limbs; patients with first suspected episode of unprovoked DVT of the lower limbs and patients with episode of unprovoked DVT of the lower limbs at third month of follow-up	Other: ultrasound elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of the density of the clots measured by elastosonography, assessing the elastic deformability of the thrombus, and correlating it with the time of occurrence of the thrombosis (fresh or three month aged clots)	1 year

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale ASL 6, Livorno
• Investigators: Study Chair: Nicola Mumoli, M.D., Department of Internal Medicine, Livorno Hospital, Livorno, Italy

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 21, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 18, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: Azienda USL Toscana Nord Ovest