NCT05413837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

July 6, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

June 6, 2022

Last Update Submit

April 13, 2023

Conditions

Keywords

venous sinusanatomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The diameters of venous sinus and small veins in Chinese healthy individuals

    On the day of examination

  • Serum biomarkers in Chinese healthy individuals

    On the day of examination

Interventions

Contrast enhanced-magnatic resonance venography(CE-MRV)and other magnetic resonance imaging methods are used to estimate the anatomy of cerebral venous sinus.

Elisa or omics analysis is used to test the level of biomarker in blood.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Chinese healthy individuals aged 18-35 years without clinical symtoms and cerebral venous diseases

You may qualify if:

  • Age 18 - 35 years old.
  • Confirmed no intracranial diseases, congenital abnormalities such as intracranial hematoma, tumor, vascular malformation, hydrocephalus, etc.
  • Voluntarily signed informed consent.

You may not qualify if:

  • Any clinical history, including hypertension, diabetes, coronary heart disease, hematologic and rheumatic immune system diseases,cervical spondylosis, anxiety, depression, insomnia, etc.
  • 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.
  • Any history of craniocerebral trauma or surgery that affected the existence and running of veins.Unhealthy habits such as smoking, heavy drinking, etc.
  • Women who are pregnant or in preparation for pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu hospital;Capital Medical University

Beijin, XI Cheng District, 100053, China

RECRUITING

Related 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.

    PMID: 28494642BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from enrolled participants are drawn by nurse using containing coagulant tubes.

MeSH Terms

Conditions

Sinus Thrombosis, Intracranial

Condition Hierarchy (Ancestors)

Intracranial ThrombosisIntracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Study Officials

  • Xunming Ji, MD.PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD.PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 10, 2022

Study Start

July 6, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations