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出境医 / 临床实验 / Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography

Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography

Study Description
Brief Summary:
The purpose of this research study is to collect data/measurements that are routinely collected in standard of care cerebral angiogram

Condition or disease Intervention/treatment
Cerebral Angiogram Procedure: Standard of Care Cerebral Angiogram Group

Detailed Description:

Research for this study is to determine how the injection of contrast material influences vessel measurements, as these measurements guide device selection when interventions are warranted.

The data will be used to determine if there is a significant change in vessel diameter with intra-arterial injection of contrast material in cerebral angiography, how changes in force of contrast injection augments the significance of the changes in vessel geometry, and the extent of propagation downstream from the catheter tip that such changes in vessel diameter are detected and found to be significant, as these changes could potentially lead to less optimal device selection by providing an overestimation of true vessel diameter.

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 12, 2018
Arms and Interventions
Group/Cohort Intervention/treatment
Standard of Care Cerebral Angiogram Group
Participants undergoing a standard of care cerebral angiogram.
 Procedure: Standard of Care Cerebral Angiogram Group

Subjects will undergo the standard of care cerebral angiogram and any intervention(s) (when applicable) that were discussed with their provider, following the standard procedural protocol for the procedure at WFBMC. There are no additional interventions or changes to the planned intervention(s) that will take place by agreeing to participate in the study.

The data collected from this procedure, following the standard of care protocol, will include the following: force of injection of contrast material for each angiographic run (peak pressure associated with injection, duration of peak, and area under pressure curve), volume of contrast utilized, images from the procedure, measurements of vessel diameter at defined distances from the catheter tip utilizing the images, catheter type, any additional device(s) (when applicable) utilized during the procedure, and if spasmolytic agents are utilized (including dose and time of administration).
Outcome Measures
Primary Outcome Measures :
  1. Peak pressure associated with injection [ Time Frame: During procedure, up to 10 minutes ]
    The effort force of injection will be measured and recorded for each run using a standard arterial line pressure transducer setup that attaches to the guide catheter, with data acquired via Mediocollector (a program that allows for quantitative recording of data. The duration of peak pressure will be collected.

  2. The duration of peak pressure [ Time Frame: During procedure, up to 10 minutes ]
    The duration of peak pressure will be collected.


Other Outcome Measures:
  1. Vessel Diameter [ Time Frame: During the procedure, up to 10 minutes ]
    Measurement of vessel diameter


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram that are anticipated to have multiple images per standard view (a minimum of 2 images for an individual view required for the necessary data collection).

Patients that are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.

Criteria

Inclusion Criteria:

  • Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram who are anticipated to have a minimum of 2 images for an individual view required for the necessary data collection

Exclusion Criteria:

  • Patients who are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
Contacts and Locations

Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: Kyle M Fargen, MD, Ph.D Wake Forest University Health Sciences
Tracking Information
First Submitted Date May 7, 2019
First Posted Date May 14, 2019
Last Update Posted Date January 7, 2020
Actual Study Start Date July 12, 2018
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
  • Peak pressure associated with injection [ Time Frame: During procedure, up to 10 minutes ]
    The effort force of injection will be measured and recorded for each run using a standard arterial line pressure transducer setup that attaches to the guide catheter, with data acquired via Mediocollector (a program that allows for quantitative recording of data. The duration of peak pressure will be collected.
  • The duration of peak pressure [ Time Frame: During procedure, up to 10 minutes ]
    The duration of peak pressure will be collected.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2019) 		Vessel Diameter [ Time Frame: During the procedure, up to 10 minutes ]
Measurement of vessel diameter
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography
Official Title Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography
Brief Summary The purpose of this research study is to collect data/measurements that are routinely collected in standard of care cerebral angiogram
Detailed Description

Research for this study is to determine how the injection of contrast material influences vessel measurements, as these measurements guide device selection when interventions are warranted.

The data will be used to determine if there is a significant change in vessel diameter with intra-arterial injection of contrast material in cerebral angiography, how changes in force of contrast injection augments the significance of the changes in vessel geometry, and the extent of propagation downstream from the catheter tip that such changes in vessel diameter are detected and found to be significant, as these changes could potentially lead to less optimal device selection by providing an overestimation of true vessel diameter.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram that are anticipated to have multiple images per standard view (a minimum of 2 images for an individual view required for the necessary data collection).

Patients that are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
Condition Cerebral Angiogram
Intervention Procedure: Standard of Care Cerebral Angiogram Group

Subjects will undergo the standard of care cerebral angiogram and any intervention(s) (when applicable) that were discussed with their provider, following the standard procedural protocol for the procedure at WFBMC. There are no additional interventions or changes to the planned intervention(s) that will take place by agreeing to participate in the study.

The data collected from this procedure, following the standard of care protocol, will include the following: force of injection of contrast material for each angiographic run (peak pressure associated with injection, duration of peak, and area under pressure curve), volume of contrast utilized, images from the procedure, measurements of vessel diameter at defined distances from the catheter tip utilizing the images, catheter type, any additional device(s) (when applicable) utilized during the procedure, and if spasmolytic agents are utilized (including dose and time of administration).
Study Groups/Cohorts Standard of Care Cerebral Angiogram Group
Participants undergoing a standard of care cerebral angiogram.
Intervention: Procedure: Standard of Care Cerebral Angiogram Group
Publications *
  • S P Sutera a, Skalak R. The History of Poiseuille's Law. Annual Review of Fluid Mechanics. 1993;25(1):1-20
  • Yousem DM, Trinh BC. Injection rates for neuroangiography: results of a survey. AJNR Am J Neuroradiol. 2001 Nov-Dec;22(10):1838-40.
  • Hao Q, Lieber BB. Dispersive Transport of Angiographic Contrast During Antegrade Arterial Injection. Cardiovasc Eng Technol. 2012 Jun 1;3(2):171-178. Epub 2012 Apr 13.
  • Alexander MD, Nicholson AD, Darflinger RJ, Settecase F, Cooke DL, Dowd CF, Amans MR, Higashida RT, Hetts SW, Halbach VV. Effects on vessel measurement accuracy and subsequent occlusion after calcium channel blocker infusion during treatment of cerebral aneurysms with the Pipeline embolization device. Interv Neuroradiol. 2017 Feb;23(1):47-51. doi: 10.1177/1591019916674916. Epub 2016 Oct 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 3, 2020) 		1
Original Estimated Enrollment
 (submitted: May 10, 2019) 		100
Actual Study Completion Date July 12, 2018
Actual Primary Completion Date July 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients receiving care at WFBMC that will be undergoing a standard of care cerebral angiogram who are anticipated to have a minimum of 2 images for an individual view required for the necessary data collection

Exclusion Criteria:

  • Patients who are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03949023
Other Study ID Numbers IRB00049517
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
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Kyle M Fargen, MD, Ph.D Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date January 2020

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