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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 3, 2009
Last Updated Date	July 19, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 3, 2009)	more feasible and accurate way to detect significant coronary artery disease [ Time Frame: upon completion of the study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00837369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Regadenoson R-T Perfusion Imaging Trial
Official Title ^ICMJE	Regadenoson Real Time Perfusion Imaging Trial
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Condition ^ICMJE	Coronary Artery Disease Myocardial Perfusion Abnormalities
Intervention ^ICMJE	Drug: Regadenoson 400ug IV bolus injection, single dosage Other Names: Definity (Lantheus Medical Imaging) Lipid encapsulated microbubbles
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	December 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00837369
Other Study ID Numbers ^ICMJE	566-08-FB
Has Data Monitoring Committee	Yes
Responsible Party	Thomas R. Porter, MD, University of Nebraska
Study Sponsor ^ICMJE	University of Nebraska
Collaborators ^ICMJE	Mayo Clinic Astellas Pharma Inc
Investigators ^ICMJE	Not Provided
Information Provided By	University of Nebraska
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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