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Detection of Ultrasound Contrast Signals in the Cerebral Circulation

Primary Purpose

Brain Vascular Disorders, Coronary Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound on Temporal Bone
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Vascular Disorders

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Nebraska Medicial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 Transcranial imaging using Doppler Ultrasound

Arm Description

Transcranial imaging using Doppler ultrasound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2007
Last Updated
August 9, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00579241
Brief Title
Detection of Ultrasound Contrast Signals in the Cerebral Circulation
Official Title
Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Study Start Date
April 27, 2006 (Actual)
Primary Completion Date
December 12, 2009 (Actual)
Study Completion Date
December 12, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Vascular Disorders, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Transcranial imaging using Doppler Ultrasound
Arm Type
Experimental
Arm Description
Transcranial imaging using Doppler ultrasound
Intervention Type
Procedure
Intervention Name(s)
Ultrasound on Temporal Bone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detect abnormalities in cerebral blood flow
Description
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.
Time Frame
immediate
Secondary Outcome Measure Information:
Title
if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities.
Description
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.
Time Frame
within 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Porter, MD
Organizational Affiliation
University of Nebraska Medicial Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medicial Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

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Detection of Ultrasound Contrast Signals in the Cerebral Circulation

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