Clinical trial NCT03948971: Prospective Measurement of Normal Venous Sinus Pressures
Official title: Venous Sinus Pressures in Normal Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Venous Pressures
Keywords: cerebral arteriography
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients aged 18-60 years determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Superior Sagittal Sinus Pressure
timeFrame: during venogram, up to 10 minutes
measure: Torcula Sinus Pressure
timeFrame: during venogram, up to 10 minutes
measure: Dominant Transverse Sinus
timeFrame: during venogram, up to 10 minutes
measure: Dominant Transverse-Sigmoid Sinus Junction
timeFrame: during venogram, up to 10 minutes
measure: Dominant Sigmoid Sinus
timeFrame: during venogram, up to 10 minutes
measure: Dominant Internal Jugular Vein
timeFrame: during venogram, up to 10 minutes
measure: Central Venous Pressures
timeFrame: during venogram, up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Univesity Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kyle Fargen, MD
role: PRINCIPAL_INVESTIGATOR
References: