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

Sponsor

Capital Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04492332

Collaborator

(none)

137

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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). The purpose of this study was to investigate the physiological role of VVC in BTSS patients.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Venous Collaterals Serum Uric Acid Intracranial Hypertension Bilateral Transverse Sinus Stenosis	Diagnostic Test: standard lumbar puncture	N/A

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

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 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.	Diagnostic Test: 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.
Sham Comparator: 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.	Diagnostic Test: 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.
Active Comparator: 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.	Diagnostic Test: 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.
Active Comparator: 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.	Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

intracranial pressure (ICP) [at admission]
ICP was detected by standard lumbar puncture

Secondary Outcome Measures

serum uric acid (UA) [at admission]
Fasting venous blood was withdrawn simultaneously to assess serum UA.

Other Outcome Measures

Triad of IH: papilledema [at admission]
Fundus photography was graded by using modified Frisén's grade
Triad of IH: headache [at admission]
10-point Numeric Pain Rating Scale (NPRS)
Triad of IH: tinnitus [at admission]
questionnaires for tinnitus handicap inventory (THI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.