Clinical trial NCT04492332: Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis
Official title: Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: intracranial pressure (ICP)
timeFrame: at admission
Secondary outcomes:
measure: serum uric acid (UA)
timeFrame: at admission
Other outcomes:
measure: Triad of IH: papilledema
timeFrame: at admission
measure: Triad of IH: headache
timeFrame: at admission
measure: Triad of IH: tinnitus
timeFrame: at admission
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
Study officials:
References: