Regadenoson R-T Perfusion Imaging Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837369
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : July 23, 2012
Mayo Clinic
Astellas Pharma Inc
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska

February 3, 2009
February 5, 2009
July 23, 2012
May 2009
March 2011   (Final data collection date for primary outcome measure)
more feasible and accurate way to detect significant coronary artery disease [ Time Frame: upon completion of the study ]
Same as current
Complete list of historical versions of study NCT00837369 on Archive Site
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Regadenoson R-T Perfusion Imaging Trial
Regadenoson Real Time Perfusion Imaging Trial
To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the A2A Receptor agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Myocardial Perfusion Abnormalities
Drug: Regadenoson
400ug IV bolus injection, single dosage
Other Names:
  • Definity (Lantheus Medical Imaging)
  • Lipid encapsulated microbubbles
Experimental: 1
RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.
Intervention: Drug: Regadenoson
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female. Age ≥30 years.
  • Resting Left Ventricular Ejection Fraction > 40% using Simpson's biplane measurement.
  • Scheduled for coronary angiography within 30 days of the Regadenoson stress test.
  • Negative urine pregnancy test within 2 hours of ultrasound contrast administration required of 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.
  • Agreeable to undergo the additional stress test and coronary angiography
  • Have at least an intermediate likelihood of coronary disease based on the following clinical profile
  • Good apical echo images with at least 50% of each coronary artery territory well visualized.

Exclusion Criteria:

  • Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
  • Pregnancy or lactation.
  • Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
  • Life expectancy of less than two months or terminally ill.
  • Congestive (idiopathic) or hypertrophic cardiomyopathy.
  • Known left main disease.
  • Heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis.
  • Resting Left Ventricular Ejection Fraction < 40%
  • Large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation.
  • Early positive treadmill EKG within the first stage of the test.
  • History of >1st degree heart block, sick sinus syndrome or high grade AV block without a pacemaker.
  • Dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours.
  • Participation In another investigational study within one month of this study.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Thomas R. Porter, MD, University of Nebraska
University of Nebraska
  • Mayo Clinic
  • Astellas Pharma Inc
Not Provided
University of Nebraska
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP