Prospective Measurement of Normal Venous Sinus Pressures

NCT03948971 | Recruiting

• 1 other identifier: IRB00057618
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Venous Pressures

Keywords

cerebral arteriography

Outcome Measures

Primary Outcomes (7)

• 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  Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  Torcula sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  Dominant transverse sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  dominant transverse-sigmoid sinus junction will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  Dominant sigmoid sinus will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  Dominant internal jugular vein will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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  Central venous pressures will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.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

Study Arms (1)

Venogram Group

OTHER

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

Procedure: Venogram

Interventions

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.

Venogram Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Candidates for elective cerebral arteriography

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Study Officials

• Kyle Fargen, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Hawley

CONTACT

336-716-4031; kimberly.hawley@advocatehealth.org

Kyle Fargen, MD

CONTACT

kyle.fargen@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patients aged 18-60 years determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: January 13, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)