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出境医 / 临床实验 / Prospective Measurement of Normal Venous Sinus Pressures

Prospective Measurement of Normal Venous Sinus Pressures

Study Description
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

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

Locations
Layout table for location information
United States, North Carolina
Wake Forest Univesity Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Kyle Fargen, MD Wake Forest University Health Sciences
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Measurement of Normal Venous Sinus Pressures
Official Title  ICMJE Venous Sinus Pressures in Normal Individuals
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Intracranial Venous Pressures
Intervention  ICMJE 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.
Study Arms  ICMJE Venogram Group
Participants in this group have a scheduled clinically indicated a cerebral angiogram procedure and will undergo a Venogram.
Intervention: Procedure: Venogram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimberly Hawley 336-716-4031 khawley@wakehealth.edu
Contact: Kyle Fargen, MD kfargen@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948971
Other Study ID Numbers  ICMJE IRB00057618
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Fargen, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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