Phase 1
Completed N=46
Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
Source: ClinicalTrials.gov NCT01161121 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Difference in FFR Between IV Adenosine and IV Regadenoson — 0.84; 0.84 ratio (Pd/Pa)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in FFR Between IV Adenosine and IV Regadenoson |
0.84; 0.84 | — |
| SECONDARY Heart Rate Changes With Drug |
70.8; 72.4; 81.7; 90.4 | — |
| SECONDARY Side Effects of Medication Administration |
14; 13; 16; 13; 27; 28 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01161121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.