Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT03948971

Conditions

Intracranial Venous Pressures

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Venogram

Study Details

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

Study ID

NCT03948971

Start date

Jan 13, 2020

Status verified date

Dec, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Venogram Group

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

Interventions

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.

Primary outcome measure

  • Superior Sagittal Sinus Pressure [ Time Frame: during venogram, up to 10 minutes ]
  • Torcula Sinus Pressure [ Time Frame: during venogram, up to 10 minutes ]
  • Dominant Transverse Sinus [ Time Frame: during venogram, up to 10 minutes ]
  • Dominant Transverse-Sigmoid Sinus Junction [ Time Frame: during venogram, up to 10 minutes ]
  • Dominant Sigmoid Sinus [ Time Frame: during venogram, up to 10 minutes ]
  • Dominant Internal Jugular Vein [ Time Frame: during venogram, up to 10 minutes ]
  • Central Venous Pressures [ Time Frame: during venogram, up to 10 minutes ]

Central Contacts and Locations

Central contacts

Kimberly Hawley

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

Kyle Fargen, MD

kyle.fargen@advocatehealth.org

Locations

Wake Forest Univesity Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 26, 2026

Last verified

Dec, 2025

Keywords

  • cerebral arteriography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-26.