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Prospective Measurement of Normal Venous Sinus Pressures

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ClinicalTrials.gov Identifier: NCT03948971
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Intracranial Venous Pressures Procedure: Venogram Not Applicable

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.

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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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Venogram Group
Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.
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 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Kimberly Hawley 336-716-4031 khawley@wakehealth.edu
Contact: Kyle Fargen, MD kfargen@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Univesity Health Sciences Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Kyle Fargen, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03948971     History of Changes
Other Study ID Numbers: IRB00057618
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
cerebral arteriography