Detection of Ultrasound Contrast Signals in the Cerebral Circulation

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease; Brain Vascular Disorders
• Interventions: Procedure: Ultrasound on Temporal Bone

• Registration Number: NCT00579241
• Lead Sponsor: University of Nebraska

Brief Summary

To Determine whether transcranial ultrasound can detect the presence of intravenously injected microbubbles used routinely for dobutamine stress echocardiography.

Detailed Description

The purpose of this study is to determine whether the intravenous microbubbles used to improve border delineation during dobutamine stress echocardiographies (DSE) can be detected within the cerebral circulation.

Study Timeline

• Study Start: 2006-04-27
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2009-12-12
• Study Completion: 2009-12-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• male or female age >19 years of age
• scheduled for a stress echocardiogram
• negative urine pregnancy test within two hours of ultrasound contrast administration required for females of childbearing age unless post-menopausal or with evidence of surgical sterilization
• be conscious and coherent, and able to communicate effectively with trial personnel

Exclusion Criteria

• pregnant or lactation
• life expectancy of less than 2 months or terminally ill
• Known or suspected hypersensitivity to ultrasound contrast agent used for the study
• complicated hemodynamic instability
• Known left main disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 Transcranial imaging using Doppler Ultrasound	Ultrasound on Temporal Bone	Transcranial imaging using Doppler ultrasound

Primary Outcome Measures

Name	Time	Method
Detect abnormalities in cerebral blood flow	immediate	All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.

Secondary Outcome Measures

Name	Time	Method
if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.	within 30 minutes	All Patients undergoing dobutamine stress echocardiography have an intravenous line placed and a continuous infusion of a commercially available contrast agent administered. Prior to contrast infusion, baseline transcranial ultrasound images at 0.4 mechanical index using low mechanical index pulses and color Doppler will be performed and recorded. After this the contrast infusion will begin, and resting cardiac images will occur.

Trial Locations

Locations (1)

University of Nebraska Medicial Center; 🇺🇸 Omaha, Nebraska, United States