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Not yet recruitingNCT06025591SWE-DVTUpdated Oct 19, 2023

Shear-Wave Elastography in Deep Vein Thrombosis

An observational study in Deep Vein Thrombosis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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
02

Conditions studied

  • Deep Vein Thrombosis
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 200 is close to the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with newly diagnosed deep venous thrombosis of the lower and upper extremities afferent to the Operating Units of Fondazione Policlinico Universitario Agostino Gemelli IRCSS involved in the study (i.e. Medical Angiology Service, Internal Medicine and Thromboembolic Pathologies and Outpatient Clinic of Internal Medicine and Gastroenterology of the C.E.M.A.D. - Center for Diseases of the Digestive System),who will meet the inclusion criteria.

Inclusion criteria

  • Age ≥ 18 years;
  • New diagnosis of proximal deep venous thrombosis, Distal deep venous thrombosis of the lower limbs, deep venous thrombosis of the upper limbs, defined as arising within 72 hours prior to the first ultrasound evaluation;
  • Availability for follow-up at the above-mentioned Units in Fondazione Policlinico Universitario Agostino Gemelli IRCSS.;
  • written informed consent to the participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years;
  • Pregnant or lactating women;
  • Life expectancy of less than 6 months;
  • Previous performance of drug-mechanical thrombolysis for the treatment of index thrombotic episode;
  • Technical impossibility/clinical unreliability of ultrasound evaluation with elastography due to: (a) obligate decubitus of the patient's limb, (b) non-removable occluding dressings, (c) excessive thickness of subcutaneous fatty tissue or edema;
  • Previous thrombotic episode at the same site of the thromboembolic episode under study.
  • Refusal to sign informed consent to participate in the study.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Fibrosis Index

    Evaluation of a potential time-dependent cut-off of Fibrosis Index discriminating between acute (within 72h) and chronic (3-6-9-12 months) thrombosis.

    Time frame: 1 month

07

Study locations

1 site
  • Fondazione Policlinico Gemelli IRCCS
    Roma, 00168, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06025591
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Zocco Maria Assunta (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Sep 6, 2023
Start date
Oct 2023 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Sep 2025 (estimated)
Last update
Oct 19, 2023

Study contacts

Maria Assunta Zocco
Contact
mariaassunta.zocco@policlinicogemelli.it
00393470597805

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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