Status:
COMPLETED
Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
University of Florida
Astellas Pharma US, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 f...
Detailed Description
Patients with clinical indications to be assessed by fractional flow reserve (FFR) will be included. Following diagnostic angiography in the catheterization lab, the patient will have a guide catheter...
Eligibility Criteria
Inclusion
- male or female patients greater than 18 years old (If female, pt. must be post-menopausal, surgically sterile, or be non-pregnant as determined by a negative urine or serum beta human chorionic gonadotropin (B-HCG) pregnancy test within 24 hours prior to enrollment.
- Provided written consent approved by Institutional Review Board and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
- Have at least one coronary stenosis (greater or equal to 40% but less than 70\& narrowing by visual inspection) and technically accessible coronary artery into which the pressure wire may be introduced.
Exclusion
- ST elevation myocardial infarction
- Cardiogenic shock
- Pregnancy
- Total vessel occlusion
- Extremely tortuous coronary arteries
- Second and third degree heart block without pacemaker
- Severe chronic obstructive pulmonary disease and active bronchospasm
- Less than age 18 years
- Have received theophylline, aminophylline, pentoxifylline or dipyridamole within 12 hours of FFR measurement.
- Has severe 3 vessel disease defined by \>80% luminal narrowing by visual inspection
- Known hypersensitivity to adenosine or regadenoson
- Recent uncontrolled ventricular arrhythmia
- History of greater than Type I atrioventricular block, symptomatic resting bradycardia, sick sinus syndrome (without permanent pacemaker)
- History of heart transplantation
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01161121
Start Date
July 1 2010
End Date
April 1 2013
Last Update
June 23 2017
Active Locations (2)
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1
University of Florida
Jacksonville, Florida, United States, 32209
2
St. Louis University
St Louis, Missouri, United States, 63110