IddvtIDDVTNCT06596941
Ultrasound Assessment of Isolated Distal Deep Vein Thrombosis
An observational study of Iddvt and Pulmonary Embolism (PE), run by Ruijin Hospital at 1 site in China.
Trial summary
Retrospective assessment of ultrasound and clinical characteristics of patients with IDDVT, development of a pulmonary embolism risk prediction model for thrombus, and provision of appropriate diagnostic and therapeutic recommendations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iddvt, Pulmonary Embolism (PE)
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both male and female
Who may be able to join
- Diagnosis of new-onset IDDVT confirmed by lower limb vascular ultrasound; presence/absence of pulmonary embolism clarified by pulmonary artery CTA; ultrasound and pulmonary artery CTA results spanning no more than 5 days.
Who cannot join
- Anticoagulation therapy in the last month; pregnancy or puerperium; recurrent DVT or PE.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Retrospective assessment of ultrasound and clinical characteristics of patients with IDDVT, development of a pulmonary embolism risk prediction model for thrombus, and provision of appropriate diagnostic and therapeutic recommendations.
- Conditions
- Iddvt, Pulmonary Embolism (PE)
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
IDDVT with PE
IDDVT patients with concomitant PE
Measured: At the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IddvtStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596941
- Sponsor's protocol ID
- MR-31-24-020092
- Acronym
- IDDVT
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Isolated Distal Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT06596941
- Acronym / sponsor ID
- IDDVT / MR-31-24-020092
- Conditions
- Iddvt, Pulmonary Embolism (PE)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Retrospective assessment of ultrasound and clinical characteristics of patients with IDDVT, development of a pulmonary embolism risk prediction model for thrombus, and provision of appropriate diagnostic and therapeutic recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both male and female
Key inclusion criteria (1 listed)
- Diagnosis of new-onset IDDVT confirmed by lower limb vascular ultrasound; presence/absence of pulmonary embolism clarified by pulmonary artery CTA; ultrasound and pulmonary artery CTA results spanning no more than 5 days.
Key exclusion criteria (1 listed)
- Anticoagulation therapy in the last month; pregnancy or puerperium; recurrent DVT or PE.
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
IDDVT with PE
Time frame: At the initial visit
IDDVT patients with concomitant PE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Iddvt and Pulmonary Embolism (PE), run by Ruijin Hospital at 1 site in China.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
IDDVT with PE (time frame: At the initial visit). 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 Sep 2024.