Influence of Contrast Injection Force on the Accuracy of Vessel Measurements in Cerebral Angiography
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|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
|Condition or disease||Intervention/treatment|
|Cerebral Angiogram||Procedure: Standard of Care Cerebral Angiogram Group|
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|
|Actual Enrollment :||1 participants|
|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|
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).
- 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.
- Vessel Diameter [ Time Frame: During the procedure, up to 10 minutes ]Measurement of vessel diameter
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
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Kyle M Fargen, MD, Ph.D||Wake Forest University Health Sciences|