Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals

April 13, 2023 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • XI Cheng District
      • Beijin, XI Cheng District, China, 100053
        • Recruiting
        • Xuanwu hospital;Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The anotomy and variation of venous sinus in Chinese healthy individuals
Time Frame: On the day of examination
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The diameters of venous sinus and small veins in Chinese healthy individuals
Time Frame: On the day of examination
Measuring the diameters of venous sinus and small veins assessed with contrast-enhanced MR venography
On the day of examination
Serum biomarkers in Chinese healthy individuals
Time Frame: On the day of examination
The level of biomarkers are detected using Elisa or omics analysis
On the day of examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVSAV-HI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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