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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03949023
Enrollment
1
Registered
2019-05-14
Start date
2018-07-12
Completion date
2018-07-12
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Angiogram

Keywords

Neurovascular Condition, Contrast Injections, Brain

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.

Interventions

PROCEDUREStandard 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).

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Peak pressure associated with injectionDuring procedure, up to 10 minutesThe 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 pressureDuring procedure, up to 10 minutesThe duration of peak pressure will be collected.

Other

MeasureTime frameDescription
Vessel DiameterDuring the procedure, up to 10 minutesMeasurement of vessel diameter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026