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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949023
Recruitment Status : Terminated (unable to perform refinement of study procedures to better capture information needed)
First Posted : May 14, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

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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

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).





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



Information from the National Library of Medicine

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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.

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): NCT03949023


Locations
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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
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Principal Investigator: Kyle M Fargen, MD, Ph.D Wake Forest University Health Sciences
Publications:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03949023    
Other Study ID Numbers: IRB00049517
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
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:
Neurovascular Condition
Contrast Injections
Brain