Status:
COMPLETED
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
Astellas Pharma Global Development, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will...
Eligibility Criteria
Inclusion
- Patients undergoing elective left heart catheterization
- Age ≥ 18 years (female not of child bearing potential)
- Able to provide written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01482169
Start Date
March 1 2012
End Date
September 1 2014
Last Update
May 11 2018
Active Locations (1)
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1
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121