Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ochsner Health System
• Collaborator: Astellas Pharma Global Development, Inc.
• Treatments: Adenosine; Regadenoson

Criteria

Inclusion Criteria:

• Patients undergoing elective left heart catheterization

• Age ≥ 18 years (female not of child bearing potential)

• Able to provide written informed consent

Exclusion Criteria:

• Contraindications to administration of either Adenoscan® or Regadenoson

• High degree AV block, sick sinus syndrome without a functioning pacemaker

• Symptomatic bradycardia

• Recent STEMI (< 5 days)

• Recent NSTEMI (<5 days) if the peak CK is > 1000 IU

• Dipyridamole use within 24 hours

• Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline

• Known severe bronchoconstrictive lung disease