Regadenoson R-T Perfusion Imaging Trial

Coronary Artery Disease Clinical Trial

Official title:

Regadenoson Real Time Perfusion Imaging Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837369
• Other study ID #: 566-08-FB
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: July 19, 2012
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Myocardial Perfusion Abnormalities

Intervention

Drug:
• Regadenoson
400ug IV bolus injection, single dosage

Locations

Country	Name	City	State
United States	University of Nebraska Medicial Center	Omaha	Nebraska
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska	Astellas Pharma Inc, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	more feasible and accurate way to detect significant coronary artery disease		upon completion of the study	No