Regadenoson R-T Perfusion Imaging Trial

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT00837369

Collaborator

Mayo Clinic (Other), Astellas Pharma Inc (Industry)

100

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To exam the feasibility and accuracy of RTPE during vasodilator stress with 400micrograms of the A2A Receptor 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Perfusion Abnormalities	Drug: Regadenoson	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Regadenoson Real Time Perfusion Imaging Trial

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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

Arm

Intervention/Treatment

Experimental: 1

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

Outcome Measures

Primary Outcome Measures

more feasible and accurate way to detect significant coronary artery disease [upon completion of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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., 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	University of Nebraska Medicial Center	Omaha	Nebraska	United States	68105

Sponsors and Collaborators

University of Nebraska
Mayo Clinic
Astellas Pharma Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas R. Porter, MD, Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT00837369

Other Study ID Numbers:

566-08-FB

First Posted:

Feb 5, 2009

Last Update Posted:

Jul 23, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Thomas R. Porter, MD, Professor, University of Nebraska

Stress echocardiography

SPECT

Myocardial perfusion imaging

Additional relevant MeSH terms:

Coronary Artery Disease

Regadenoson

Study Results

No Results Posted as of Jul 23, 2012