Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis

NCT ID: NCT04492332

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Vertebral Venous Collaterals Serum Uric Acid Intracranial Hypertension Bilateral Transverse Sinus Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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normal controls with VVC

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.

Group Type SHAM_COMPARATOR

standard lumbar puncture

Intervention Type DIAGNOSTIC_TEST

Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.

normal controls without VVC

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.

Group Type SHAM_COMPARATOR

standard lumbar puncture

Intervention Type DIAGNOSTIC_TEST

Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.

BTSS patients with VVC

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.

Group Type ACTIVE_COMPARATOR

standard lumbar puncture

Intervention Type DIAGNOSTIC_TEST

Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.

BTSS patients without VVC

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.

Group Type ACTIVE_COMPARATOR

standard lumbar puncture

Intervention Type DIAGNOSTIC_TEST

Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.

Interventions

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standard lumbar puncture

Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* BTSS confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA).

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuanwu Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BTSS-ICP

Identifier Type: -

Identifier Source: org_study_id

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