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Regadenoson Real Time Perfusion Imaging Trial-Optison

Primary Purpose

Coronary Artery Disease, Myocardial Perfusion Abnormalities

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Regadenoson; Optison
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Stress Echocardiography, Real-Time Perfusion Imaging, Regadenoson, Optison

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regadenoson; Optison

Arm Description

Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.

Outcomes

Primary Outcome Measures

Number of Participants With Coronary Stenosis
Measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2011
Last Updated
September 26, 2023
Sponsor
University of Nebraska
Collaborators
Astellas Pharma US, Inc., GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01489176
Brief Title
Regadenoson Real Time Perfusion Imaging Trial-Optison
Official Title
Regadenoson Stress Real-Time Myocardial Perfusion Echocardiography for Detection of Coronary Artery Disease Feasibility and Accuracy of Two Different Ultrasound Contrast Agents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2012 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
December 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Astellas Pharma US, Inc., GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Perfusion Abnormalities
Keywords
Stress Echocardiography, Real-Time Perfusion Imaging, Regadenoson, Optison

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regadenoson; Optison
Arm Type
Experimental
Arm Description
Use of Regadenoson as the chemical stress agent using Optison as a contrast agent during stress echocardiography.
Intervention Type
Drug
Intervention Name(s)
Regadenoson; Optison
Other Intervention Name(s)
Lexiscan is the brand name for regadenoson.
Intervention Description
A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
Primary Outcome Measure Information:
Title
Number of Participants With Coronary Stenosis
Description
Measurements will be analyzed to identify a coronary stenosis >50% in diameter by quantitative cardiac angiography.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Porter, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

Links:
URL
https://doi.org/10.1016/j.echo.2015.08.011
Description
Journal of the American Society of Echocardiography

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Regadenoson Real Time Perfusion Imaging Trial-Optison

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