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.
Coronary Artery Disease
Myocardial Perfusion Abnormalities
Drug: Regadenoson; Optison
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Regadenoson Real Time Perfusion Imaging Trial-Optison|
- Identification of Coronary Stenosis [ Time Frame: One year ] [ Designated as safety issue: No ]Sensitivity, specificity, and accuracy measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Regadenoson; Optison
Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489176
|Contact: Mary M Adolphson, RNemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator: Sharon Mulvagh, MD|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68105|
|Principal Investigator: Thomas R. Porter, MD|
|Principal Investigator:||Thomas R Porter, MD||University of Nebraska|