Regadenoson R-T Perfusion Imaging Trial
This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
First received: February 3, 2009
Last updated: July 19, 2012
Last verified: July 2012
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
Coronary Artery Disease
Myocardial Perfusion Abnormalities
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
||Regadenoson Real Time Perfusion Imaging Trial
Primary Outcome Measures:
- more feasible and accurate way to detect significant coronary artery disease [ Time Frame: upon completion of the study ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
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.
400ug IV bolus injection, single dosage
- Definity (Lantheus Medical Imaging)
- Lipid encapsulated microbubbles
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837369
|Rochester, Minnesota, United States, 55905 |
|University of Nebraska Medicial Center
|Omaha, Nebraska, United States, 68105 |
University of Nebraska
Astellas Pharma Inc
No publications provided
||Thomas R. Porter, MD, Professor, University of Nebraska
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 3, 2009
||July 19, 2012
||United States: Food and Drug Administration
Keywords provided by University of Nebraska:
Myocardial perfusion imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Coronary Artery Disease
Arterial Occlusive Diseases
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs