Regadenoson Real Time Perfusion Imaging Trial-Optison
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|ClinicalTrials.gov Identifier: NCT01489176|
Recruitment Status : Unknown
Verified September 2012 by Thomas R. Porter, MD, University of Nebraska.
Recruitment status was: Recruiting
First Posted : December 9, 2011
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Perfusion Abnormalities||Drug: Regadenoson; Optison||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Regadenoson Real Time Perfusion Imaging Trial-Optison|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489176
|Contact: Mary M Adolphson, RNfirstname.lastname@example.org|
|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|