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Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161121
First Posted: July 13, 2010
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Florida
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Michael J. Lim, St. Louis University
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Drug: adenosine Drug: regadenoson Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael J. Lim, St. Louis University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 46
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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 placed in the artery to be assessed followed by placing a pressure guidewire down the coronary vessel and past the lesion of interest. FFR will be measured in the traditional manner, with intravenous adenosine infusing at 140 mcg/kg/min until maximal steady state hyperemia is reached. At this point, the FFR will be recorded as Pd (distal pressure from the pressure wire in the coronary artery) divided by Pa (proximal pressure from the guide catheter). The adenosine infusion will then be stopped and the patient's hemodynamics allowed to return to baseline. Once baseline state is again achieved, an intravenous bolus of regadenson (0.4 mg) will be given and FFR will be remeasured as the lowest steady state Pd/Pa. Patients will be enrolled at two sites, The University of Florida - where FFR will be measured alone, and Saint Louis University, where coronary flow will be measured simultaneously to evaluate the effect of regadenoson on coronary flow velocity as compared to adenosine. The primary endpoint of the study will be to compare the FFR achieved with adeonsine to that obtained with regadenoson.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
United States, Missouri
St. Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
University of Florida
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Michael J Lim, MD St. Louis University
  More Information

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 Submitted: July 6, 2010
First Posted: July 13, 2010
Results First Submitted: July 30, 2013
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