Intracranial Venous PressuresNCT03948971
Prospective Measurement of Normal Venous Sinus Pressures
A study testing Venogram in people with Intracranial Venous Pressures, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intracranial Venous Pressures
- What is being tested?
- Venogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Candidates for elective cerebral arteriography
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyle Fargen, MD contact
United States1 site, 1 recruiting
- Recruiting
Wake Forest Univesity Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Venous Sinus Pressures in Normal Individuals
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.
Read the 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.
- 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.
- Conditions
- Intracranial Venous Pressures
- Being tested
- Venogram
- Keywords
- cerebral arteriography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenogramProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Venogram Group | Other | Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram. Receives: Procedure: Venogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior Sagittal Sinus Pressure
Superior sagittal sinus pressure will be recorded in mmHg as the catheter is withdrawn into the jugular bulb.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: during venogram, up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start13 Jan 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Venous PressuresStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adult patients aged 18-60 years determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Fargen, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948971
- Sponsor's protocol ID
- IRB00057618
- Status last verified
- Dec 2025
- First submitted
- 10 May 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Sinus Pressures in Normal Individuals
- ClinicalTrials.gov ID
- NCT03948971
- Acronym / sponsor ID
- IRB00057618
- Conditions
- Intracranial Venous Pressures
- Keywords
- cerebral arteriography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adult patients aged 18-60 years determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study.
| Arm | Type | Receives |
|---|---|---|
| Venogram Group | Other | Procedure: VenogramParticipants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Candidates for elective cerebral arteriography
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenogramThe 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. | Procedure or surgery | Venogram Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Fargen, MD contact
Kyle Fargen, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venogram in people with Intracranial Venous Pressures, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Hawley (336-716-4031, kimberly.hawley@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superior Sagittal Sinus Pressure (time frame: during venogram, up to 10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.