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Regadenoson Real Time Perfusion Imaging Trial-Optison

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Thomas R. Porter, MD, University of Nebraska Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489176
First Posted: December 9, 2011
Last Update Posted: September 26, 2012
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.
Collaborators:
Astellas Pharma US, Inc.
GE Healthcare
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska Medical Center
December 2, 2011
December 9, 2011
September 26, 2012
September 2012
September 2013   (Final data collection date for primary outcome measure)
Identification of Coronary Stenosis [ Time Frame: One year ]
Sensitivity, specificity, and accuracy measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.
More feasible and accurate way to detect coronary artery disease [ Time Frame: One year ]
These measures will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.
Complete list of historical versions of study NCT01489176 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Regadenoson Real Time Perfusion Imaging Trial-Optison
Regadenoson Real Time Perfusion Imaging Trial-Optison
The purpose if this study is to examine how effective Regadenoson is in detecting coronary artery disease during a stress echocardiogram when Optison is administered. Optison is a contrast agent that improves the images of the heart on the echocardiogram (echo) machine. Optison is approved by the Food and Drug Administration (FDA) to use during stress echocardiograms. Regadenoson is a commercially available rapid acting stress agent that is used to chemically increase the heart rate and is approved for nuclear imaging tests. Regadenoson is a FDA approved drug but not for the intended use in this study.

Stress perfusion imaging has primarily been done with radionuclide scintigraphy or single photon emission computed tomography (SPECT) and has not reached its full clinical potential because of the poor spatial resolution of SPECT, increased expense of this procedure, patient exposure to ionizing radiation, and lack of availability. The A2A receptor agonist Regadenoson has been utilized to detect myocardial perfusion abnormalities during SPECT myocardial perfusion imaging.

A 100 patient pilot study (Regadenoson Real Time Perfusion Imaging Trial, IRB #566-08-FB) demonstrated the feasibility and accuracy of real-time perfusion echocardiography (RTPE) in detecting coronary artery disease following Regadenoson bolus injection and Definity as an ultrasound contrast agent. The aim of this study is to determine whether similar feasibility and accuracy can be achieved with Optison (a Food and Drug Administration approved ultrasound contrast agent that differs slightly in microbubble size and composition) in detecting coronary artery disease (CAD) following Regadenoson bolus injection. As with the original study, sensitivity, specificity, and accuracy of perfusion and wall motion analysis to identify a coronary stenosis >50% in diameter by quantitative angiography will be analyzed.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Coronary Artery Disease
  • Myocardial Perfusion Abnormalities
Drug: Regadenoson; Optison
A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Other Name: Lexiscan is the brand name for regadenoson.
Experimental: Regadenoson; Optison
Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.
Intervention: Drug: Regadenoson; Optison
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
September 2013
September 2013   (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 (which is being performed for research purposes only, not for clinical care) and coronary angiography (which is being performed for clinical care) based on the following clinical profile: Have at least an intermediate likelihood of coronary disease based.
  • 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 ECG 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.
  • Anyone in whom a stress test should not be performed prior to cardiac catheterization.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01489176
555-11-FB
Yes
Not Provided
Not Provided
Thomas R. Porter, MD, University of Nebraska Medical Center
Thomas R. Porter, MD
  • Astellas Pharma US, Inc.
  • GE Healthcare
Principal Investigator: Thomas R Porter, MD University of Nebraska
University of Nebraska
September 2012

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