Shear-Wave Elastography in Deep Vein Thrombosis

NCT06025591 | Unknown

• 1 other identifier: 5833
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Vein Thrombosis

Outcome Measures

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.

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805; mariaassunta.zocco@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IT (1)