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Regadenoson R-T Perfusion Imaging Trial

This study has been completed.
Sponsor:
Collaborators:
Mayo Clinic
Astellas Pharma Inc
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00837369
First received: February 3, 2009
Last updated: July 19, 2012
Last verified: July 2012

February 3, 2009
July 19, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837369 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837369
566-08-FB
Yes
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