Venous ThrombosisNCT04732299
Staging and Prognosis of Deep Venous Thrombosis of Lower Extremities
An observational study of Venous Thrombosis, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal coagulation of blood in the deep vein, which usually occurs in the lower extremities. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- MRI examination
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Feb 2024
- How long will I take part?
- 3 Months
- 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: The people included in this study are patients suspected of deep venous thrombosis of lower extremities for the first time and should be older than 18 years old.
Who may be able to join
- More than 18 years old
- Suspected deep venous thrombosis of lower extremities
- No treatment related to deep venous thrombosis of lower extremities
Who cannot join
- Contraindication of magnetic resonance imaging
- Previous history of deep venous thrombosis
- History of allergy to magnetic resonance contrast agents
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Staging Diagnosis and Prognosis of Lower Extremity Deep Venous Thrombosis Based on Magnetic Resonance Imaging: a Prospective Study
Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal coagulation of blood in the deep vein, which usually occurs in the lower extremities. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death. Therefore, the accurate diagnosis and curative effect evaluation of DVT are of great significance to the prognosis of patients. At present, the treatment of DVT includes systematic thrombolysis and catheter contact thrombolysis, among which oral drug thrombolysis has certain advantages in clinical application. However, in the process of thrombosis, the composition of thrombus is different in different periods, thus, defining the staging of thrombus plays an important role in the decision-making of drug treatment. In view of the high resolution of magnetic resonance imaging of soft tissue, thrombus can be directly imaged. Therefore, this project will take the staging diagnosis of deep venous thrombosis as the starting point. Through the development of magnetic resonance imaging, this paper tries to solve the problem of evaluating the therapeutic effect of deep venous thrombosis in clinic.
Read the detailed description
Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal blood coagulation in the deep vein, which usually occurs in the lower extremities. DVT is common in patients with limb immobilization (such as after major orthopedic surgery), severe trauma, tumor, coma or long-term bedridden patients. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death.
In the process of thrombosis, the components of thrombus are different in different stages. in the acute stage of thrombosis, the consumption of blood fibroses is less, mainly in the thrombolytic therapy of activating plasminogen; in the subacute and chronic phase of thrombosis, the consumption of fibrinolytic enzyme is more, anticoagulant therapy is needed to prolong the clotting time. Therefore, defining the staging of thrombus is the key to make a reasonable treatment plan and improve the therapeutic effect of DVT. The guidelines recommend that for patients with moderate or high likelihood of DVT, if two consecutive ultrasound examinations are negative, further X-ray venography, CT venography or magnetic resonance venous thrombosis direct imaging are recommended. Among them, magnetic resonance thrombus direct imaging depends on the content of methemoglobin in the body and will not produce radiation to the human body. it can not only accurately judge the thrombus in the pelvic and inferior vena cava, but also show the details of the changes in the vein wall or lumen. Therefore, magnetic resonance thrombus direct imaging has a certain potential in the differential diagnosis of acute, subacute and old thrombus. In this study, we will use magnetic resonance thrombus direct imaging to stage and judge the efficacy of drug treatment, in order to provide help for clinic.
- Conditions
- Venous Thrombosis
- Being tested
- MRI examination
- Keywords
- MRI, Venous Thrombosis, Staging, Prognosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationOther
Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.
| Study group | Role | What they receive |
|---|---|---|
| Acute thrombus group | Within 14 days after onset Receives: Other: MRI examination | |
| Subacute thrombus group | During 15-30 days after onset Receives: Other: MRI examination | |
| Chronic thrombosis group | More than 15-30 days after onset Receives: Other: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus-muscle signal-to-noise ratio
Quantitative analysis of thrombus was performed by magnetic resonance thrombography for the first time, and the curative effect was evaluated again 3 months after clinical treatment.
Measured: The interval between two MRI examinations per patient is 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Dec 2021 (estimated)
- Primary completion15 Jun 2022 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732299
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-014
- Status last verified
- Aug 2021
- First submitted
- 28 Jan 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dronkers CE, Sramek A, Huisman MV, Klok FA. Accurate diagnosis of iliac vein thrombosis in pregnancy with magnetic resonance direct thrombus imaging (MRDTI). BMJ Case Rep. 2016 Dec 13;2016:bcr2016218091. doi: 10.1136/bcr-2016-218091.
PubMed 27965311Karande GY, Hedgire SS, Sanchez Y, Baliyan V, Mishra V, Ganguli S, Prabhakar AM. Advanced imaging in acute and chronic deep vein thrombosis. Cardiovasc Diagn Ther. 2016 Dec;6(6):493-507. doi: 10.21037/cdt.2016.12.06.
PubMed 28123971Mendichovszky IA, Priest AN, Bowden DJ, Hunter S, Joubert I, Hilborne S, Graves MJ, Baglin T, Lomas DJ. Combined MR direct thrombus imaging and non-contrast magnetic resonance venography reveal the evolution of deep vein thrombosis: a feasibility study. Eur Radiol. 2017 Jun;27(6):2326-2332. doi: 10.1007/s00330-016-4555-4. Epub 2016 Aug 30.
PubMed 27578046Xie G, Chen H, He X, Liang J, Deng W, He Z, Ye Y, Yang Q, Bi X, Liu X, Li D, Fan Z. Black-blood thrombus imaging (BTI): a contrast-free cardiovascular magnetic resonance approach for the diagnosis of non-acute deep vein thrombosis. J Cardiovasc Magn Reson. 2017 Jan 18;19(1):4. doi: 10.1186/s12968-016-0320-8.
PubMed 28095878Chen H, He X, Xie G, Liang J, Ye Y, Deng W, He Z, Liu D, Li D, Liu X, Fan Z. Cardiovascular magnetic resonance black-blood thrombus imaging for the diagnosis of acute deep vein thrombosis at 1.5 Tesla. J Cardiovasc Magn Reson. 2018 Jun 25;20(1):42. doi: 10.1186/s12968-018-0459-6.
PubMed 29936910Zhuang G, Tang C, He X, Liang J, He Z, Ye Y, Deng W, Liu D, Chen H. DANTE-SPACE: a new technical tool for DVT on 1.5T MRI. Int J Cardiovasc Imaging. 2019 Dec;35(12):2231-2237. doi: 10.1007/s10554-019-01675-w. Epub 2019 Aug 24.
PubMed 31446527
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging Diagnosis and Prognosis of Lower Extremity Deep Venous Thrombosis Based on Magnetic Resonance Imaging: a Prospective Study
- ClinicalTrials.gov ID
- NCT04732299
- Acronym / sponsor ID
- XJTU1AF-CRF-2020-014
- Conditions
- Venous Thrombosis
- Keywords
- MRI, Venous Thrombosis, Staging, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 1 Feb 2021 (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.
Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal coagulation of blood in the deep vein, which usually occurs in the lower extremities. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death. Therefore, the accurate diagnosis and curative effect evaluation of DVT are of great significance to the prognosis of patients. At present, the treatment of DVT includes systematic thrombolysis and catheter contact thrombolysis, among which oral drug thrombolysis has certain advantages in clinical application. However, in the process of thrombosis, the composition of thrombus is different in different periods, thus, defining the staging of thrombus plays an important role in the decision-making of drug treatment. In view of the high resolution of magnetic resonance imaging of soft tissue, thrombus can be directly imaged. Therefore, this project will take the staging diagnosis of deep venous thrombosis as the starting point. Through the development of magnetic resonance imaging, this paper tries to solve the problem of evaluating the therapeutic effect of deep venous thrombosis in clinic.
Detailed description
Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal blood coagulation in the deep vein, which usually occurs in the lower extremities. DVT is common in patients with limb immobilization (such as after major orthopedic surgery), severe trauma, tumor, coma or long-term bedridden patients. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death.
In the process of thrombosis, the components of thrombus are different in different stages. in the acute stage of thrombosis, the consumption of blood fibroses is less, mainly in the thrombolytic therapy of activating plasminogen; in the subacute and chronic phase of thrombosis, the consumption of fibrinolytic enzyme is more, anticoagulant therapy is needed to prolong the clotting time. Therefore, defining the staging of thrombus is the key to make a reasonable treatment plan and improve the therapeutic effect of DVT. The guidelines recommend that for patients with moderate or high likelihood of DVT, if two consecutive ultrasound examinations are negative, further X-ray venography, CT venography or magnetic resonance venous thrombosis direct imaging are recommended. Among them, magnetic resonance thrombus direct imaging depends on the content of methemoglobin in the body and will not produce radiation to the human body. it can not only accurately judge the thrombus in the pelvic and inferior vena cava, but also show the details of the changes in the vein wall or lumen. Therefore, magnetic resonance thrombus direct imaging has a certain potential in the differential diagnosis of acute, subacute and old thrombus. In this study, we will use magnetic resonance thrombus direct imaging to stage and judge the efficacy of drug treatment, in order to provide help for clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute thrombus group | – | Other: MRI examinationWithin 14 days after onset |
| Subacute thrombus group | – | Other: MRI examinationDuring 15-30 days after onset |
| Chronic thrombosis group | – | Other: MRI examinationMore than 15-30 days after onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The people included in this study are patients suspected of deep venous thrombosis of lower extremities for the first time and should be older than 18 years old.
Key inclusion criteria (3 listed)
- More than 18 years old
- Suspected deep venous thrombosis of lower extremities
- No treatment related to deep venous thrombosis of lower extremities
Key exclusion criteria (3 listed)
- Contraindication of magnetic resonance imaging
- Previous history of deep venous thrombosis
- History of allergy to magnetic resonance contrast agents
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 |
|---|---|---|
| MRI examinationMagnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage. | Other | Acute thrombus group, Chronic thrombosis group, Subacute thrombus group |
Primary outcome
Thrombus-muscle signal-to-noise ratio
Time frame: The interval between two MRI examinations per patient is 3 months.
Quantitative analysis of thrombus was performed by magnetic resonance thrombography for the first time, and the curative effect was evaluated again 3 months after clinical treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background: PubMed 27965311Dronkers CE, Sramek A, Huisman MV, Klok FA. Accurate diagnosis of iliac vein thrombosis in pregnancy with magnetic resonance direct thrombus imaging (MRDTI). BMJ Case Rep. 2016 Dec 13;2016:bcr2016218091. doi: 10.1136/bcr-2016-218091.
- Background: PubMed 28123971Karande GY, Hedgire SS, Sanchez Y, Baliyan V, Mishra V, Ganguli S, Prabhakar AM. Advanced imaging in acute and chronic deep vein thrombosis. Cardiovasc Diagn Ther. 2016 Dec;6(6):493-507. doi: 10.21037/cdt.2016.12.06.
- Background: PubMed 27578046Mendichovszky IA, Priest AN, Bowden DJ, Hunter S, Joubert I, Hilborne S, Graves MJ, Baglin T, Lomas DJ. Combined MR direct thrombus imaging and non-contrast magnetic resonance venography reveal the evolution of deep vein thrombosis: a feasibility study. Eur Radiol. 2017 Jun;27(6):2326-2332. doi: 10.1007/s00330-016-4555-4. Epub 2016 Aug 30.
- Background: PubMed 28095878Xie G, Chen H, He X, Liang J, Deng W, He Z, Ye Y, Yang Q, Bi X, Liu X, Li D, Fan Z. Black-blood thrombus imaging (BTI): a contrast-free cardiovascular magnetic resonance approach for the diagnosis of non-acute deep vein thrombosis. J Cardiovasc Magn Reson. 2017 Jan 18;19(1):4. doi: 10.1186/s12968-016-0320-8.
- Background: PubMed 29936910Chen H, He X, Xie G, Liang J, Ye Y, Deng W, He Z, Liu D, Li D, Liu X, Fan Z. Cardiovascular magnetic resonance black-blood thrombus imaging for the diagnosis of acute deep vein thrombosis at 1.5 Tesla. J Cardiovasc Magn Reson. 2018 Jun 25;20(1):42. doi: 10.1186/s12968-018-0459-6.
- Background: PubMed 31446527Zhuang G, Tang C, He X, Liang J, He Z, Ye Y, Deng W, Liu D, Chen H. DANTE-SPACE: a new technical tool for DVT on 1.5T MRI. Int J Cardiovasc Imaging. 2019 Dec;35(12):2231-2237. doi: 10.1007/s10554-019-01675-w. Epub 2019 Aug 24.
- Individual participant dataSharing planned: No
Related trials for Venous Thrombosis
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis, run by First Affiliated Hospital Xi'an Jiaotong University.
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 3 inclusion and 3 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Zhe Liu, Mr. (0086-13259756822, imagingliuzhe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus-muscle signal-to-noise ratio (time frame: The interval between two MRI examinations per patient is 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04732299, which also lists 6 linked publications.
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 Aug 2021.