Prospective Measurement of Normal Venous Sinus Pressures
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT03948971
- Status
- Recruiting
Conditions
- Intracranial Venous Pressures
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Venogram — PROCEDUREThe 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 Next, the venous sinus pressure waveforms will be recorded as the catheter is withdrawn into the jugular bulb and then in the superior vena cava to obtain a central venous pressure.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 Details
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.
Key Dates
- Start date
- Jan 13, 2020
- Status verified
- Dec 2025
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Other: Venogram GroupParticipants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.
Primary Outcome Measure
Superior Sagittal Sinus Pressure [ Time Frame: during venogram, up to 10 minutes ]
Central Contacts
- Kimberly Hawley336-716-4031
- Kyle Fargen, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina | 27157 | - |