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

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

Study Overview

• Status: Terminated
• Conditions: Cerebral Angiogram
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The duration of peak pressure	The duration of peak pressure will be collected.	During procedure, up to 10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vessel Diameter	Measurement of vessel diameter	During the procedure, up to 10 minutes

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Kyle M Fargen, MD, Ph.D, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Brain; Neurovascular Condition; Contrast Injections
• Other Study ID Numbers: IRB00049517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No