Deep Vein Thrombosis Clinical Trial
Official title:
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.
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