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

NCT04492332 | Completed

• 1 other identifier: BTSS-ICP
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• intracranial pressure (ICP)

  ICP was detected by standard lumbar puncture

  at admission

Secondary Outcomes (1)

• serum uric acid (UA)

  at admission

Other Outcomes (3)

• Triad of IH: papilledema

  at admission

• Triad of IH: headache

  at admission

• Triad of IH: tinnitus

  at admission

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: standard lumbar puncture

Interventions

standard lumbar puncture 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 patients without VVC; normal controls with VVC; normal controls without VVC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 30, 2020
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

CN (1)