Prospective Measurement of Normal Venous Sinus Pressures

Not Applicable

Recruiting

• Conditions: Intracranial Venous Pressures
• Interventions: Procedure: Venogram

• Registration Number: NCT03948971
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this research is to document normal intracranial venous sinus pressures. Participants who need to have a cerebral angiogram to evaluate a medical problem not related to Idiopathic Intracranial Hypertension (IIH) will be invited to participate. Participation in this research will not require any extra visits. The intervention will take place in the interventional radiology suite when the subject has an angiogram. IIH is a condition that causes increased pressure in the brain in the absence of a tumor or other diseases that may be causing symptoms. Symptoms include headaches and visual disturbances not explained by other things. In IIH there is a narrowing in the sinuses of the brain that causes the increased pressure.

Detailed Description

Patients will be prospectively enrolled into the study. All adult patients, aged of 18-60, determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study. Patients consenting to participate and enrolled in the study will first undergo their standard cerebral angiogram procedure, as clinically indicated. Once the procedure is completed, enrolled subjects will then undergo the study intervention.

1. Insertion of an additional catheter in the femoral vein.

2. Navigation of the catheter into the internal jugular bulb and then catheter navigation into the superior sagittal sinus will result in additional fluoroscopic time (requires \~60 seconds of additional fluoroscopy time; carries a minimum risk of vessel perforation or other untoward event \[incidence of complication associated with this procedure in the PI patient series is 0%\]). There is additionally some ear pain that can happen with this Venogram.

3. 5-10 minutes of additional procedure time. Much of this time period is merely a waiting period while the pressures stabilize and are recorded.

4. An additional venogram injection through the catheter which exposes subjects to an additional 1-2 ml of contrast dye and 3-4 seconds of additional fluoroscopy time and its associated radiation dose.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Study Start: 2020-01-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Candidates for elective cerebral arteriography

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Exclusion Criteria

• All patients with active, or a history of, intracranial venous pathology (arteriovenous malformation, arteriovenous fistulae, idiopathic intracranial hypertension, venous sinus thrombosis).
• Patients with severe daily headaches or symptoms of idiopathic intracranial hypertension will also be excluded.
• Body mass index > 35.
• Known diagnosis of heart failure or pulmonary hypertension.
• Pregnant women will be excluded due to the radiation risk associated with Angiogram and Venogram.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venogram Group	Venogram	Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.

Primary Outcome Measures

Name	Time	Method
Dominant Internal Jugular Vein	during venogram, up to 10 minutes	Dominant internal jugular vein will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Superior Sagittal Sinus Pressure	during venogram, up to 10 minutes	Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Transverse Sinus	during venogram, up to 10 minutes	Dominant transverse sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Transverse-Sigmoid Sinus Junction	during venogram, up to 10 minutes	dominant transverse-sigmoid sinus junction will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Central Venous Pressures	during venogram, up to 10 minutes	Central venous pressures will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Sigmoid Sinus	during venogram, up to 10 minutes	Dominant sigmoid sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Torcula Sinus Pressure	during venogram, up to 10 minutes	Torcula sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.

Trial Locations

Locations (1)

Wake Forest Univesity Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States