Clinical trial NCT03949023: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Angiogram
Keywords: Neurovascular Condition
Contrast Injections
Brain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Peak pressure associated with injection
timeFrame: During procedure, up to 10 minutes
measure: The duration of peak pressure
timeFrame: During procedure, up to 10 minutes
Secondary outcomes:
Other outcomes:
measure: Vessel Diameter
timeFrame: During the procedure, up to 10 minutes
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kyle M Fargen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: S P Sutera a, Skalak R. The History of Poiseuille's Law. Annual Review of Fluid Mechanics. 1993;25(1):1-20
citation: Yousem DM, Trinh BC. Injection rates for neuroangiography: results of a survey. AJNR Am J Neuroradiol. 2001 Nov-Dec;22(10):1838-40.
citation: Hao Q, Lieber BB. Dispersive Transport of Angiographic Contrast During Antegrade Arterial Injection. Cardiovasc Eng Technol. 2012 Jun 1;3(2):171-178. doi: 10.1007/s13239-012-0090-x. Epub 2012 Apr 13.
citation: 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.