Prospective Measurement of Normal Venous Sinus Pressures
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|ClinicalTrials.gov Identifier: NCT03948971|
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Venous Pressures||Procedure: Venogram||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Venous Sinus Pressures in Normal Individuals|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948971
|Contact: Kimberly Hawleyfirstname.lastname@example.org|
|Contact: Kyle Fargen, MDemail@example.com|
|United States, North Carolina|
|Wake Forest Univesity Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Kyle Fargen, MD||Wake Forest University Health Sciences|