Prospective Measurement of Normal Venous Sinus Pressures

Venous Sinus Pressures in Normal Individuals

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Venous Pressures
• Intervention / Treatment: Procedure: Venogram

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Hawley; Phone Number: 336-716-4031; Email: khawley@wakehealth.edu
• Study Contact Backup: Name: Kyle Fargen, MD; Email: kfargen@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Univesity Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Candidates for elective cerebral arteriography

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Venogram Group; Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.

Procedure: Venogram; The 5 French (5F) diagnostic catheter will be navigated into the inferior then superior vena cava and then into the internal jugular bulb on the dominant venous side (as determined from the arteriographic images). Next, a 0.027 inch microcatheter will be navigated using fluoroscopic guidance into the superior sagittal sinus and a venogram will then performed by injecting a small dose of contrast. Next, the venous sinus pressure waveforms will be recorded as the catheter is withdrawn into the jugular bulb and then in the superior vena cava to obtain a central venous pressure. Once completed, the catheters will be removed and the sheaths will be removed. Manual pressure will be held at the venous access site for a few minutes. The arterial sheath will be closed based upon standard arteriogram protocol.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Kyle Fargen, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cerebral arteriography
• Other Study ID Numbers: IRB00057618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No