Clinical Trial: Regadenoson to Achieve Maximal Hyperemia for Fractional Flow Reserve in the Catheterization Lab

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve

Brief Summary: The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising patient safety.

Detailed Summary:
Sponsor: St. Louis University

Current Primary Outcome: Difference in FFR and Coronary Flow Reserve measurements between IV adenosine and IV regadenoson [ Time Frame: Every 30 seconds during infusion through 5 minutes post infusion of adenosine and regadenoson. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Monitor for potential side effects after IV adenosine and IV regadenoson administration such as chest pain, headache, flushing, nausea or arrhythmias [ Time Frame: Every 30 seconds during infusion through 5 minutes post infusion ]

Original Secondary Outcome: Same as current

Information By: St. Louis University

Dates:
Date Received: July 6, 2010
Date Started: July 2010
Date Completion: August 2013
Last Updated: November 13, 2012
Last Verified: November 2012