Deep Vein ThrombosisNCT02809638
A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis and Compression Ultrasound, run by Azienda Sanitaria Locale ASL 6, Livorno at 1 site in Italy.
Trial summary
In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT). Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis, Compression Ultrasound, Elastography
- What is being tested?
- ultrasound elastography
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2015to 21 Jun 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study, we will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique.
Who may be able to join
- acute first episode of unprovoked DVT of lower limbs
- chronic first episode of unprovoked DVT of lower limbs (at third month of follow up)
Who cannot join
- previous episodes of DVT
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Elastography: a New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis
In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT).
Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. One potential technique to age DVT is ultrasound elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well known that thrombi harden as they age. The aim of this study will be to assess the ability of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique. The demographic data, medical history, physical examination and the results of CUS and ultrasound elastography will be collected in a case report form (CRF) by another investigator who does not perform the examinations. The blinded CRF will be submitted to a dedicated committee for statistical analysis.
- Being tested
- ultrasound elastography
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound elastographyOther
| Study group | Role | What they receive |
|---|---|---|
| DVT of the lower limbs | patients with first suspected episode of unprovoked DVT of the lower limbs and patients with episode of unprovoked DVT of the lower limbs at third month of follow-up Receives: Other: ultrasound elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.
Measured: 1 year
Secondary outcomes (1)
Change of the density of the clots measured by elastosonography, assessing the elastic deformability of the thrombus, and correlating it with the time of occurrence of the thrombosis (fresh or three month aged clots)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startAug 2015
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale ASL 6, Livorno
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nicola Mumoli, Azienda Sanitaria Locale ASL 6, Livorno
- Investigators
- Nicola Mumoli, M.D., Study chair, Department of Internal Medicine, Livorno Hospital, Livorno, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809638
- Sponsor's protocol ID
- Azienda USL Toscana Nord Ovest
- Status last verified
- Jan 2019
- First submitted
- 30 May 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Elastography: a New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT02809638
- Acronym / sponsor ID
- Azienda USL Toscana Nord Ovest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale ASL 6, LivornoOther government
- Study start
- Aug 2015
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT).
Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. One potential technique to age DVT is ultrasound elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well known that thrombi harden as they age. The aim of this study will be to assess the ability of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique. The demographic data, medical history, physical examination and the results of CUS and ultrasound elastography will be collected in a case report form (CRF) by another investigator who does not perform the examinations. The blinded CRF will be submitted to a dedicated committee for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DVT of the lower limbs | – | Other: ultrasound elastographypatients with first suspected episode of unprovoked DVT of the lower limbs and patients with episode of unprovoked DVT of the lower limbs at third month of follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique.
Key inclusion criteria (2 listed)
- acute first episode of unprovoked DVT of lower limbs
- chronic first episode of unprovoked DVT of lower limbs (at third month of follow up)
Key exclusion criteria (4 listed)
- previous episodes of DVT
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound elastography | Other | DVT of the lower limbs |
Primary outcome
Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography.
Time frame: 1 year
1 secondary outcome
Change of the density of the clots measured by elastosonography, assessing the elastic deformability of the thrombus, and correlating it with the time of occurrence of the thrombosis (fresh or three month aged clots)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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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.
Nicola Mumoli, M.D. study chair
Department of Internal Medicine, Livorno Hospital, Livorno, Italy
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 and Compression Ultrasound, run by Azienda Sanitaria Locale ASL 6, Livorno 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Density of clots in patients having acute or 3 month DVT of the lower limb, using the technique of elastosonography. (time frame: 1 year). 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 9 Jan 2019.