Detection of Ultrasound Contrast Signals in the Cerebral Circulation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00579241
First received: December 18, 2007
Last updated: July 19, 2012
Last verified: July 2012
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Ultrasound Contrast Signals in the Cerebral Circulation During Stress Echocardiography

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: April 2006
Study Completion Date: April 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Nebraska
University of Nebraska Medicial Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Thomas R Porter, MD University of Nebraska Medicial Center
  More Information

No publications provided

Responsible Party: Thomas R. Porter, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00579241     History of Changes
Other Study ID Numbers: 113-06-FB
Study First Received: December 18, 2007
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebrovascular Disorders
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014