Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
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ClinicalTrials.gov Identifier: NCT01161121 |
Recruitment Status
:
Completed
First Posted
: July 13, 2010
Results First Posted
: June 19, 2017
Last Update Posted
: June 23, 2017
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Drug: adenosine Drug: regadenoson | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Adenosine then Regadenoson
Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine infusion will be administered at 140 mcg/kg for 2 minutes and once mean coronary flow velocity returns to within 15% of pre-dose value, Regadenoson IV bolus 0.4 mg/5 ml will be administered followed by a 5 cc normal saline flush.
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Drug: adenosine
Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.
Other Name: Adenoscan(adenosine)
Drug: regadenoson
Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Other Name: Lexiscan
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- Difference in FFR Between IV Adenosine and IV Regadenoson [ Time Frame: At maximal, steady-state hyperemia ]FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson
- Heart Rate Changes With Drug [ Time Frame: During drug infusion and until restoration of baseline hemodynamics ]Maximal heart rate documented following the administration of each agent
- Side Effects of Medication Administration [ Time Frame: During drug infusion and until restoration of baseline hemodynamics ]Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161121
United States, Florida | |
University of Florida | |
Jacksonville, Florida, United States, 32209 | |
United States, Missouri | |
St. Louis University | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Michael J Lim, MD | St. Louis University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael J. Lim, Director, Division of Cardiology, St. Louis University |
ClinicalTrials.gov Identifier: | NCT01161121 History of Changes |
Other Study ID Numbers: |
Rega-9I06 |
First Posted: | July 13, 2010 Key Record Dates |
Results First Posted: | June 19, 2017 |
Last Update Posted: | June 23, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Michael J. Lim, St. Louis University:
Fractional flow reserve adenosine regadenoson |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hyperemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Adenosine Regadenoson Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Vasodilator Agents Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adenosine A2 Receptor Agonists |