Clinical trial NCT00837369: Regadenoson R-T Perfusion Imaging Trial
Official title: Regadenoson Real Time Perfusion Imaging Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Myocardial Perfusion Abnormalities
Keywords: Stress echocardiography
SPECT
Myocardial perfusion imaging
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Astellas Pharma Inc
First posted: 2009-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

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 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.

Primary outcomes:
measure: Detection of Coronary Artery Disease With Real-time Perfusion Echocardiography During Regadenoson Stress
timeFrame: 1 hour observation post perfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medicial Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: