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

Terminated

• Conditions: Cerebral Angiogram
• Interventions: Procedure: Standard of Care Cerebral Angiogram Group

• Registration Number: NCT03949023
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2018-07-12
• Primary Completion: 2018-07-12
• Study Completion: 2018-07-12
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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Exclusion Criteria

• Patients who are anticipated to have less than 2 images for each standard view collected from their cerebral angiogram.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care Cerebral Angiogram Group	Standard of Care Cerebral Angiogram Group	Participants undergoing a standard of care cerebral angiogram.

Primary Outcome Measures

Name	Time	Method
Peak pressure associated with injection	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	During procedure, up to 10 minutes	The duration of peak pressure will be collected.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States