Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals

Venous Sinus Thrombosis, Cranial Clinical Trial

Official title:

Imaging Research on Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413837
• Other study ID #: CVSAV-HI
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: Capital Medical University
• Contact: Xunming Ji, MD.PhD
• Phone: 010-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The anatomical characteristics of veins and venous sinus result in great differences between cerebral venous system diseases and cerebral artery diseases in etiology, pathophysiology and clinical features.Therefore, understanding the anatomy and variation of normal venous sinuses is essential to identify the intracranial venous lesions.

Description:

The classification of venous sinus and its variation based on the autopsy of patients can not fully reflect the real anatomy and variation of venous sinus in human, and the targeted research on healthy people is still unknown. The main purpose of this research is to use multimodal magnetic resonance technology to study the variation of venous sinus in Chinese healthy population, to preliminarily improve the anatomical classification of venous sinus in Chinese , to verify the the correlation between venous sinus variation and various non-genetic factors at the same time, as well as establishing reliable quantitative evaluation indicators.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 35 years old.

2. Confirmed no intracranial diseases, congenital abnormalities such as intracranial hematoma, tumor, vascular malformation, hydrocephalus, etc.

3. Voluntarily signed informed consent.

Exclusion Criteria:

1. Any clinical history, including hypertension, diabetes, coronary heart disease, hematologic and rheumatic immune system diseases,cervical spondylosis, anxiety, depression, insomnia, etc.

2. Internal jugular venous outflow disturbance : MRV from extracranial to aortic arch demonstrates variation or stenosis of the internal jugular vein, vertebral plexus, brachiocephalic vein, and superior vena cava.

3. Any history of craniocerebral trauma or surgery that affected the existence and running of veins.Unhealthy habits such as smoking, heavy drinking, etc.

4. Women who are pregnant or in preparation for pregnancy or lactation.

5. Other conditions that the researchers considered might affect the trial and inappropriate for inclusion.

Related Conditions & MeSH terms

• Sinus Thrombosis, Intracranial
• Thrombosis
• Venous Sinus Thrombosis, Cranial

Intervention

Diagnostic Test:
• anotomy and variation of venous sinus
Contrast enhanced-magnatic resonance venography(CE-MRV)and other magnetic resonance imaging methods are used to estimate the anatomy of cerebral venous sinus.
• the level of biomarker in bood
Elisa or omics analysis is used to test the level of biomarker in blood.

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin	XI Cheng District

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Cheng Y, Li WA, Fan X, Li X, Chen J, Wu Y, Meng R, Ji X. Normal anatomy and variations in the confluence of sinuses using digital subtraction angiography. Neurol Res. 2017 Jun;39(6):509-515. doi: 10.1080/01616412.2017.1323383. Epub 2017 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The anotomy and variation of venous sinus in Chinese healthy individuals	According to the connection types of superior sagittal sinus and transverse sinus at the the torcular Herophili assessed with contrast-enhanced MR venography and phase-contrast MR venography, describe the anatomical classification of venous sinus based on the anatomical descriptions of Osborn and describe the anatomical variations that are not included in the existing classification. Calculating the proportion of each type.	On the day of examination
Secondary	The diameters of venous sinus and small veins in Chinese healthy individuals	Measuring the diameters of venous sinus and small veins assessed with contrast-enhanced MR venography	On the day of examination
Secondary	Serum biomarkers in Chinese healthy individuals	The level of biomarkers are detected using Elisa or omics analysis	On the day of examination