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