Detection of Ultrasound Contrast Signals in the Cerebral Circulation - Full Text View

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00579241

Purpose

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

Condition	Intervention
Brain Vascular Disorders Coronary Artery Disease	Procedure: Ultrasound on Temporal Bone

MedlinePlus related topics: Coronary Artery Disease Ultrasound Vascular Diseases

Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Detect abnormalities in cerebral blood flow [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

if cerebral vascular disease is detected it would lead to further testing that may better identify abnormalities. [ Time Frame: within 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579241

Contacts

Contact: Thomas R Porter, MD

402-559-7977

trporter@unmc.edu

Locations

United States, Nebraska
University of Nebraska Medicial Center	Recruiting
Omaha, Nebraska, United States, 68105
Contact: Thomas R Porter, MD 402-559-7977 trporter@unmc.edu
Contact: Saritha Dodla, MD 402-559-7271 sdodla@unmc.edu

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator:

Thomas R Porter, MD

University of Nebraska Medicial Center

More Information

Responsible Party:	University of Nebraska Medical Center ( Thomas R Porter, Professor or Medicine )
Study ID Numbers:	113-06-FB
Study First Received:	December 18, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00579241
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Stress
Central Nervous System Diseases
Ischemia

Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Dobutamine
Coronary Disease
Coronary Artery Disease

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009