Clinical trial NCT05413837: Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals
Official title: Imaging Research on Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Sinus Thrombosis, Cranial
Keywords: venous sinus
anatomy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese healthy individuals aged 18-35 years without clinical symtoms and cerebral venous diseases

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The anotomy and variation of venous sinus in Chinese healthy individuals
timeFrame: On the day of examination
Secondary outcomes:
measure: The diameters of venous sinus and small veins in Chinese healthy individuals
timeFrame: On the day of examination
measure: Serum biomarkers in Chinese healthy individuals
timeFrame: On the day of examination
Other outcomes:
Locations:
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
state: XI Cheng District
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.