A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

NCT02809638 | Completed

• 1 other identifier: Azienda USL Toscana Nord Ovest
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis; Compression Ultrasound; Elastography; Elasticity Imaging Techniques

Outcome Measures

Primary Outcomes (1)

• Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.

  1 year

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

ultrasound elastography OTHER

DVT of the lower limbs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria Locale ASL 6, Livorno: lead

Study Sites (1)

Azienda USL 6 Livorno

Livorno, Tuscany, 57100, Italy

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicola Mumoli, M.D.

  Department of Internal Medicine, Livorno Hospital, Livorno, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Azienda Sanitaria Locale ASL 6, Livorno

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 22, 2016
• Study Start: August 1, 2015
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

IT (1)