Detection of Ultrasound Contrast Signals in the Cerebral Circulation

Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography

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

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Brain Vascular Disorders
• Intervention / Treatment: Procedure: Ultrasound on Temporal Bone

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medicial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1 Transcranial imaging using Doppler Ultrasound; Transcranial imaging using Doppler ultrasound

Procedure: Ultrasound on Temporal Bone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detect abnormalities in cerebral blood flow	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.	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.	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.	within 30 minutes

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska Medicial Center

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2006
• Primary Completion (Actual): December 12, 2009
• Study Completion (Actual): December 12, 2009

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimated): December 24, 2007

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Vascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 0113-06-FB