Staging and Prognosis of Deep Venous Thrombosis of Lower Extremities

NCT04732299 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-014
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Venous Thrombosis

Keywords

MRI, Venous Thrombosis, Staging, Prognosis

Outcome Measures

Primary Outcomes (1)

• 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.

  The interval between two MRI examinations per patient is 3 months.

Study Arms (3)

Acute thrombus group

Within 14 days after onset

Other: MRI examination

Subacute thrombus group

During 15-30 days after onset

Other: MRI examination

Chronic thrombosis group

More than 15-30 days after onset

Other: MRI examination

Interventions

MRI examination OTHER

Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.

Acute thrombus group; Chronic thrombosis group; Subacute thrombus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• More than 18 years old
• Suspected deep venous thrombosis of lower extremities
• No treatment related to deep venous thrombosis of lower extremities

You may not qualify if:

• Contraindication of magnetic resonance imaging
• Previous history of deep venous thrombosis
• History of allergy to magnetic resonance contrast agents

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (6)

• 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.

  PMID: 27965311 BACKGROUND

• Karande 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.

  PMID: 28123971 BACKGROUND

• Mendichovszky 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.

  PMID: 27578046 BACKGROUND

• Xie 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.

  PMID: 28095878 BACKGROUND

• Chen 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.

  PMID: 29936910 BACKGROUND

• Zhuang 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.

  PMID: 31446527 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Zhe Liu, Mr.

CONTACT

0086-13259756822; imagingliuzhe@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: December 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: February 1, 2024
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share