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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04492332
Other study ID # BTSS-ICP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2019

Study information

Verified date July 2020
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Xuanwu Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Triad of IH: papilledema Fundus photography was graded by using modified Frisén's grade at admission
Other Triad of IH: headache 10-point Numeric Pain Rating Scale (NPRS) at admission
Other Triad of IH: tinnitus questionnaires for tinnitus handicap inventory (THI) at admission
Primary intracranial pressure (ICP) ICP was detected by standard lumbar puncture at admission
Secondary serum uric acid (UA) Fasting venous blood was withdrawn simultaneously to assess serum UA. at admission
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