Detection of Ultrasound Contrast Signals in the Cerebral Circulation

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00579241
• Other study ID #: 0113-06-FB
• Status: Withdrawn
• Phase: N/A
• Start date: April 27, 2006
• Est. completion date: December 12, 2009

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 12, 2009
• Est. primary completion date: December 12, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Vascular Disorders
• Cerebrovascular Disorders
• Coronary Artery Disease
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Nebraska Medicial Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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