Regadenoson Real Time Perfusion Imaging Trial-Optison

NCT01489176 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 0555-11-FB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Myocardial Perfusion Abnormalities

Keywords

Stress Echocardiography; Real-Time Perfusion Imaging; Regadenoson; Optison

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Coronary Stenosis

  Measurements will be analyzed to identify a coronary stenosis \>50% in diameter by quantitative cardiac angiography.

  1 year

Study Arms (1)

Regadenoson; Optison

EXPERIMENTAL

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

Drug: Regadenoson; Optison

Interventions

Regadenoson; Optison DRUG

A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.

Also known as: Lexiscan is the brand name for regadenoson.

Regadenoson; Optison

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Astellas Pharma US, Inc.: collaborator
• GE Healthcare: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Related Links

• Journal of the American Society of Echocardiography

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson; FS 069

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Thomas R Porter
• Organization: University of Nebraska Medical Center

trporter@unmc.edu

402-559-5156

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 9, 2011
• Study Start: July 31, 2012
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 8, 2024
• Results First Posted: December 30, 2022

Record last verified: 2024-10

Locations

US (2)