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

Cerebral Angiogram Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03949023
• Other study ID #: IRB00049517
• Status: Terminated
• Start date: July 12, 2018
• Est. completion date: July 12, 2018

Study information

• Verified date: January 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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).

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vessel Diameter	Measurement of vessel diameter	During the procedure, up to 10 minutes
Primary	Peak pressure associated with injection	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.	During procedure, up to 10 minutes
Primary	The duration of peak pressure	The duration of peak pressure will be collected.	During procedure, up to 10 minutes