Vertebral Venous CollateralsNCT04492332
Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis
A study testing standard lumbar puncture in people with Vertebral Venous Collaterals and Serum Uric Acid, run by Capital Medical University at 1 site in China.
Trial summary
Bilateral transverse sinus stenosis (BTSS) is associated with intracranial hypertension (IH). However, not every BTSS patients presented with IH. The risk factors of IH in BTSS patients remained obscure. Vertebral venous collaterals (VVC) were often found in patients with bilateral transverse sinus stenosis (BTSS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vertebral Venous Collaterals, Serum Uric Acid, Intracranial Hypertension
- What is being tested?
- standard lumbar puncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BTSS confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA).
Who cannot join
- medicine related intracranial hypertension;
- systemic inflammation;
- moderate to severe stenosis in intracranial, carotid or vertebral arteries;
- moderate to severe stenosis in intracranial or jugular veins other than transverse sinus;
- intracranial lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral transverse sinus stenosis (BTSS) is associated with intracranial hypertension (IH). However, not every BTSS patients presented with IH. The risk factors of IH in BTSS patients remained obscure. Vertebral venous collaterals (VVC) were often found in patients with bilateral transverse sinus stenosis (BTSS). The purpose of this study was to investigate the physiological role of VVC in BTSS patients.
Read the detailed description
Bilateral transverse sinus stenosis (BTSS) is characterized by narrowing of bilateral transverse sinus which resulted in obstruction of venous reflux. The majority of BTSS patients exhibited with intracranial hypertension (IH) which manifested as a triad of headaches, tinnitus and papilledema. Stenting improved the symptoms in patients with transverse sinus stenosis (TSS) and reduced the elevated intracranial pressure (ICP). It is suggested that BTSS is one of the etiologies of IH. Since an alternative pattern of venous reflux was observed in patients with occluded superior sagittal sinus, it is postulated that altered pattern of venous reflux also exists in the presence of BTSS. The drainage of cerebral veins consists of two major pathways: transverse sinus-sigmoid sinus-internal jugular vein and vertebral venous plexus. Vertebral venous plexus is an extensive paravertebral system that provides direct venous communication between peritoneum and cranial cavity. The presence of vertebral venous collaterals (VVC) was reported in 108 consecutive patients. However, whether VVC is of physiological significance in BTSS patients remained unknown. This study was aimed to investigate the physiological role of VVC and whether it is involved in the regulation of IH and related clinical symptoms in BTSS patients.
Besides, it is presumed that serum uric acid (UA) may affect the formation of vertebral venous collaterals (VVC) and intracranial pressure (ICP). It is reported that UA inhibits the endothelial NO biological activity. High concentrations of uric acid (UA) suppresses circulating VEGF in Wistar rats and VEGF secretion in human endothelial cells. It is presumed that serum UA may affect the formation of VVC and ICP. The aim of this study is to investigate whether serum UA serves as an influencing factor of VVC and an indicator of IH in BTSS patients.
- Conditions
- Vertebral Venous Collaterals, Serum Uric Acid, Intracranial Hypertension, Bilateral Transverse Sinus Stenosis
- Being tested
- standard lumbar puncture
- Keywords
- vertebral venous collaterals, serum uric acid, Bilateral transverse sinus stenosis, intracranial hypertension
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard lumbar punctureDiagnostic test
Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.
| Study group | Role | What they receive |
|---|---|---|
| normal controls with VVC | Sham comparator | BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found. Receives: Diagnostic Test: standard lumbar puncture |
| normal controls without VVC | Sham comparator | BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found. Receives: Diagnostic Test: standard lumbar puncture |
| BTSS patients with VVC | Active comparator | BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found. Receives: Diagnostic Test: standard lumbar puncture |
| BTSS patients without VVC | Active comparator | BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found. Receives: Diagnostic Test: standard lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure (ICP)
ICP was detected by standard lumbar puncture
Measured: at admission
Secondary outcomes (1)
serum uric acid (UA)
Fasting venous blood was withdrawn simultaneously to assess serum UA.
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startJan 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Venous CollateralsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492332
- Sponsor's protocol ID
- BTSS-ICP
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis
- ClinicalTrials.gov ID
- NCT04492332
- Acronym / sponsor ID
- BTSS-ICP
- Conditions
- Vertebral Venous Collaterals, Serum Uric Acid, Intracranial Hypertension, Bilateral Transverse Sinus Stenosis
- Keywords
- vertebral venous collaterals, serum uric acid, Bilateral transverse sinus stenosis, intracranial hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jul 2020 (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.
Bilateral transverse sinus stenosis (BTSS) is associated with intracranial hypertension (IH). However, not every BTSS patients presented with IH. The risk factors of IH in BTSS patients remained obscure. Vertebral venous collaterals (VVC) were often found in patients with bilateral transverse sinus stenosis (BTSS). The purpose of this study was to investigate the physiological role of VVC in BTSS patients.
Detailed description
Bilateral transverse sinus stenosis (BTSS) is characterized by narrowing of bilateral transverse sinus which resulted in obstruction of venous reflux. The majority of BTSS patients exhibited with intracranial hypertension (IH) which manifested as a triad of headaches, tinnitus and papilledema. Stenting improved the symptoms in patients with transverse sinus stenosis (TSS) and reduced the elevated intracranial pressure (ICP). It is suggested that BTSS is one of the etiologies of IH. Since an alternative pattern of venous reflux was observed in patients with occluded superior sagittal sinus, it is postulated that altered pattern of venous reflux also exists in the presence of BTSS. The drainage of cerebral veins consists of two major pathways: transverse sinus-sigmoid sinus-internal jugular vein and vertebral venous plexus. Vertebral venous plexus is an extensive paravertebral system that provides direct venous communication between peritoneum and cranial cavity. The presence of vertebral venous collaterals (VVC) was reported in 108 consecutive patients. However, whether VVC is of physiological significance in BTSS patients remained unknown. This study was aimed to investigate the physiological role of VVC and whether it is involved in the regulation of IH and related clinical symptoms in BTSS patients.
Besides, it is presumed that serum uric acid (UA) may affect the formation of vertebral venous collaterals (VVC) and intracranial pressure (ICP). It is reported that UA inhibits the endothelial NO biological activity. High concentrations of uric acid (UA) suppresses circulating VEGF in Wistar rats and VEGF secretion in human endothelial cells. It is presumed that serum UA may affect the formation of VVC and ICP. The aim of this study is to investigate whether serum UA serves as an influencing factor of VVC and an indicator of IH in BTSS patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal controls with VVC | Sham comparator | Diagnostic Test: standard lumbar punctureBTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found. |
| normal controls without VVC | Sham comparator | Diagnostic Test: standard lumbar punctureBTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found. |
| BTSS patients with VVC | Active comparator | Diagnostic Test: standard lumbar punctureBTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found. |
| BTSS patients without VVC | Active comparator | Diagnostic Test: standard lumbar punctureBTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BTSS confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA).
Key exclusion criteria (5 listed)
- medicine related intracranial hypertension;
- systemic inflammation;
- moderate to severe stenosis in intracranial, carotid or vertebral arteries;
- moderate to severe stenosis in intracranial or jugular veins other than transverse sinus;
- intracranial lesions.
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 |
|---|---|---|
| standard lumbar punctureSubjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning. | Diagnostic test | BTSS patients with VVC, BTSS patients without VVC, normal controls with VVC, normal controls without VVC |
Primary outcome
intracranial pressure (ICP)
Time frame: at admission
ICP was detected by standard lumbar puncture
1 secondary outcome
serum uric acid (UA)
Time frame: at admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard lumbar puncture in people with Vertebral Venous Collaterals and Serum Uric Acid, 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 1 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: finished, as of the sponsor's last update on 30 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial pressure (ICP) (time frame: at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020.