Recruiting

NCT Number: NCT03948971

Prospective Measurement of Normal Venous Sinus Pressures

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intracranial Venous Pressures

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

About this study

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.

Insertion of an additional catheter in the femoral vein.
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.
5-10 minutes of additional procedure time. Much of this time period is merely a waiting period while the pressures stabilize and are recorded.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venogram

Procedure

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.

Primary outcomes

Superior Sagittal Sinus Pressure

Time frame: during venogram, up to 10 minutes

Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Torcula Sinus Pressure

Time frame: during venogram, up to 10 minutes

Torcula sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Transverse Sinus

Time frame: 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

Time frame: 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.
Dominant Sigmoid Sinus

Time frame: during venogram, up to 10 minutes

Dominant sigmoid sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Dominant Internal Jugular Vein

Time frame: during venogram, up to 10 minutes

Dominant internal jugular vein will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Central Venous Pressures

Time frame: during venogram, up to 10 minutes

Central venous pressures will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Hawley

CONTACT

[email protected]

336-716-4031

Kyle Fargen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Venous Sinus Pressures in Normal Individuals

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: May 14, 2019
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.