Deep Vein ThrombosisSWE-DVTNCT06025591
Shear-Wave Elastography in Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2023to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Ultrasound Elastography in Distinction Between Acute and Chronic Deep Vein Thrombosis: a Prospective Observational Cohort Study
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
- Conditions
- Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zocco Maria Assunta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025591
- Sponsor's protocol ID
- 5833
- Acronym
- SWE-DVT
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound Elastography in Distinction Between Acute and Chronic Deep Vein Thrombosis: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06025591
- Acronym / sponsor ID
- SWE-DVT / 5833
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibrosis Index
Time frame: 1 month
Evaluation of a potential time-dependent cut-off of Fibrosis Index discriminating between acute (within 72h) and chronic (3-6-9-12 months) thrombosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Related trials for Deep Vein Thrombosis
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Enrolling by invitationObservational study
ClotTriever® Thrombectomy System Use-Result Survey in Japan
Deep Vein Thrombosis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Assunta Zocco (00393470597805, mariaassunta.zocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis Index (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.