Regadenoson R-T Perfusion Imaging Trial

Regadenoson Real Time Perfusion Imaging Trial

To exam the feasibility and accuracy of Regadenoson real time perfusion (RTPE) Imaging during vasodilator stress with Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography.

Study Overview

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

Detailed Description

To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the adenosine receptor (A2A) agonist Regadenoson for detection of significant coronary artery disease (CAD) in patients scheduled to undergo coronary angiography. Sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis> 50% in diameter by quantitive angiography will be analyzed

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medicial 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 and coronary angiography
• Have at least an intermediate likelihood of coronary disease based on the following clinical profile
• 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., New York Heart Association (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 EKG within the first stage of the test.
• History of >1st degree heart block, sick sinus syndrome or high grade atrioventricular (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.

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: 1 Real time perfusion (RTPE) imaging following Regadenoson; RTPE studies (resting and following Regadenoson 400 ug IV bolus injection) will be performed during a continuous infusion of lipid encapsulated microbubbles (Definity, Lantheus Medical Imaging) to qualitatively and quantitatively examine wall motion and myocardial contrast enhancement.	Drug: Regadenoson; 400ug IV bolus injection, single dosage; Other Names: Definity (Lantheus Medical Imaging); Lipid encapsulated microbubbles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress	Regadenoson real-time myocardial contrast echocardiography can be used to detect coronary artery stenosis during Regadenoson stress.	1 hour observation post perfusion

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Mayo Clinic; Astellas Pharma Inc
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimated): February 5, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: SPECT; Stress echocardiography; Myocardial perfusion imaging
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine A2 Receptor Agonists; Regadenoson
• Other Study ID Numbers: 0566-08-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