Prospective Measurement of Normal Venous Sinus Pressures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venogram.
- Who it may be relevant to
- Registry conditions: Intracranial Venous Pressures. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Venous Sinus Pressures in Normal Individuals
Overview
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.
Interventions
- 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 jug
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Wake Forest Univesity Health Sciences — Winston-Salem
Identifiers
NCT: NCT03948971 · IRB00057618