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Regadenoson Real Time Perfusion Imaging Trial-Optison

Information source: University of Nebraska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Myocardial Perfusion Abnormalities

Intervention: Regadenoson; Optison (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Thomas R. Porter, MD

Official(s) and/or principal investigator(s):
Thomas R Porter, MD, Principal Investigator, Affiliation: University of Nebraska

Overall contact:
Mary M Adolphson, RN, Phone: 402-559-8084, Email: madolphson@unmc.edu

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.

Clinical Details

Official title: Regadenoson Real Time Perfusion Imaging Trial-Optison

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Identification of Coronary Stenosis

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.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Mary M Adolphson, RN, Phone: 402-559-8084, Email: madolphson@unmc.edu

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Sharon Mulvagh, MD, Principal Investigator

University of Nebraska Medical Center, Omaha, Nebraska 68105, United States; Recruiting
Thomas R. Porter, MD, Principal Investigator

Additional Information

Starting date: September 2012
Last updated: September 25, 2012

Page last updated: August 23, 2015

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