Venous Sinus Thrombosis, CranialNCT05413837
Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals
An observational study of Venous Sinus Thrombosis, Cranial, run by Capital Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Sinus Thrombosis, Cranial
- What is being tested?
- anotomy and variation of venous sinus and the level of biomarker in bood
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chinese healthy individuals aged 18-35 years without clinical symtoms and cerebral venous diseases
Who may be able to join
- Age 18 - 35 years old.
- Confirmed no intracranial diseases, congenital abnormalities such as intracranial hematoma, tumor, vascular malformation, hydrocephalus, etc.
- Voluntarily signed informed consent.
Who cannot join
- 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.
- Other conditions that the researchers considered might affect the trial and inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital;Capital Medical University
Beijin, XI Cheng District, 100053
Xunming Ji, +86-10-83198952, jixunming@vip.163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Sinus Thrombosis, Cranial
- Being tested
- anotomy and variation of venous sinus, the level of biomarker in bood
- Keywords
- venous sinus, anatomy
- Medical subject headings
- Sinus Thrombosis, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anotomy and variation of venous sinusDiagnostic test
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 boodDiagnostic test
Elisa or omics analysis is used to test the level of biomarker in blood.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of examination
Secondary outcomes (2)
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
Measured: On the day of examination
Serum biomarkers in Chinese healthy individuals
The level of biomarkers are detected using Elisa or omics analysis
Measured: On the day of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start6 Jul 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Sinus Thrombosis, CranialStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- Xunming Ji, MD.PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413837
- Sponsor's protocol ID
- CVSAV-HI
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28494642
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Research on Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05413837
- Acronym / sponsor ID
- CVSAV-HI
- Conditions
- Venous Sinus Thrombosis, Cranial
- Keywords
- venous sinus, anatomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chinese healthy individuals aged 18-35 years without clinical symtoms and cerebral venous diseases
Key inclusion criteria (3 listed)
- Age 18 - 35 years old.
- Confirmed no intracranial diseases, congenital abnormalities such as intracranial hematoma, tumor, vascular malformation, hydrocephalus, etc.
- Voluntarily signed informed consent.
Key exclusion criteria (5 listed)
- 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.
- Other conditions that the researchers considered might affect the trial and inappropriate for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anotomy and variation of venous sinusContrast enhanced-magnatic resonance venography（CE-MRV）and other magnetic resonance imaging methods are used to estimate the anatomy of cerebral venous sinus. | Diagnostic test | – |
| the level of biomarker in boodElisa or omics analysis is used to test the level of biomarker in blood. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
The diameters of venous sinus and small veins in Chinese healthy individuals
Time frame: On the day of examination
Serum biomarkers in Chinese healthy individuals
Time frame: On the day of examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 28494642Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD.PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Sinus Thrombosis, Cranial, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD.PhD (010-83199430, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The anotomy and variation of venous sinus in Chinese healthy individuals (time frame: On the day of examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.