A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

NCT ID: NCT02809638

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-06-21

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

ultrasound elastography

Intervention Type: OTHER

Interventions

ultrasound elastography

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Sanitaria Locale ASL 6, Livorno

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nicola Mumoli

Azienda Sanitaria Locale ASL 6, Livorno

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Mumoli, M.D.

Role: STUDY_CHAIR

Department of Internal Medicine, Livorno Hospital, Livorno, Italy

Locations

Azienda USL 6 Livorno

Livorno, Tuscany, Italy

Countries

Italy

Other Identifiers

Azienda USL Toscana Nord Ovest

Identifier Type: -

Identifier Source: org_study_id