Regadenoson Real Time Perfusion Imaging Trial-Optison

Regadenoson Stress Real-Time Myocardial Perfusion Echocardiography for Detection of Coronary Artery Disease Feasibility and Accuracy of Two Different Ultrasound Contrast Agents

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Myocardial Perfusion Abnormalities
• Intervention / Treatment: Drug: Regadenoson; Optison

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Lexiscan is the brand name for regadenoson.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Coronary Stenosis	Measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.	1 year

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: GE Healthcare; Astellas Pharma US, Inc.
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska

Publications and helpful links

Helpful Links

• Journal of the American Society of Echocardiography

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 2, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (Estimated): December 9, 2011

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Regadenoson; Optison; Stress Echocardiography; Real-Time Perfusion Imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: 0555-11-FB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No