Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06025591 |
| Other study ID # |
5833 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Maria Assunta Zocco |
| Phone |
00393470597805 |
| Email |
mariaassunta.zocco[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Compression ultrasonography (CUS), which is the gold-standard for the diagnosis of deep vein
thrombosis, cannot provide adequate information on the timing of the onset of thrombosis.
Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in
hepatology, could play a crucial role in distinguishing between acute and chronic deep vein
thrombosis.
This study aims at evaluating the efficacy and diagnostic and prognostic accuracy of
Shear-Wave elastography in distinguishing between acute and chronic deep vein thrombosis.
Description:
Compression ultrasonography (CUS), supplemented with color-Doppler, is the gold-standard for
the diagnosis of deep vein thrombosis. However, it cannot provide adequate information on the
timing of the onset of thrombosis, thus not allowing a distinction between acute and chronic
venous thrombosis. A few non-standardized and poorly reproducible criteria are used in
clinical practice, such as thrombus echogenicity, degree of occlusion and signs of
recanalization. The importance of the distinction between acute and chronic venous thrombosis
has therapeutic and prognostic implications, especially in patients with occasional and
asymptomatic finding of venous thrombosis or in patients with suspected thrombotic recurrence
in whom signs and symptoms may be either due to a post-thrombotic syndrome or to a new
thrombotic episode.
Shear-Wave elastography, a technique used to assess tissue elasticity and widely used in
hepatology, could play a crucial role in distinguishing between acute and chronic deep vein
thrombosis. Literature data on the use of this technique in the evaluation of deep venous
thrombosis are derived only from observational studies, both retrospective and prospective,
mainly based on comparisons between different groups of patients with acute (within 72h from
diagnosis) or subacute thrombosis at a 3-months follow-up, with the consequent risk of
confounding in the estimating the association of elasticity values to the dating of
thrombotic remnant. The few data in the literature on thrombus evolution, assessed by
single-patient serialized evaluation, refer to extremely limited case series with short
follow-up. In addition, none of these studies consider neoplastic patients, on whom there are
no data regarding the usefulness and reproducibility of the method. In accordance with
current clinical practice, patients referred to our service of Internal medicine and
Thromboembolic Pathology perform ultrasound follow-up so that the evolution of thrombotic
residual can be assessed on each patient with large case series and follow-up of longer
duration. The primary objective of the present study is to evaluate the efficacy and
diagnostic and prognostic accuracy of Shear-Wave elastography in distinguishing between acute
and chronic deep vein thrombosis.
Secondary objectives:
- Evaluation of the maximum thickness of the thrombotic residue in compression, as well as
the longitudinal extent by B-mode ultrasound method, expressed in mm, at the various
time-points of the study
- Evaluation of the degree of venous obstruction, assessed by color-Doppler ultrasound
method at the various time-points of the study
- Qualitative evaluation of the echogenicity of the thrombotic remnant, by B-mode
ultrasound method in comparison with the echogenicity of the surrounding muscle and
vascular structures, at the various time-points of the study.
- Identification of a specific signature for recanalization of deep vein thrombosis of the
lower and upper limbs
