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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
Sponsor:
Collaborators:
University of Florida
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Michael J. Lim, St. Louis University

Tracking Information
First Submitted Date  ICMJE July 6, 2010
First Posted Date  ICMJE July 13, 2010
Results First Submitted Date  ICMJE July 30, 2013
Results First Posted Date  ICMJE June 19, 2017
Last Update Posted Date June 23, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
Difference in FFR and Coronary Flow Reserve measurements between IV adenosine and IV regadenoson [ Time Frame: Every 30 seconds during infusion through 5 minutes post infusion of adenosine and regadenoson. ]
Change History Complete list of historical versions of study NCT01161121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2010)
Monitor for potential side effects after IV adenosine and IV regadenoson administration such as chest pain, headache, flushing, nausea or arrhythmias [ Time Frame: Every 30 seconds during infusion through 5 minutes post infusion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
Official Title  ICMJE Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve
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 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: adenosine
  • Drug: regadenoson
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
46
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2010)
50
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01161121
Other Study ID Numbers  ICMJE Rega-9I06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael J. Lim, St. Louis University
Study Sponsor  ICMJE St. Louis University
Collaborators  ICMJE
  • University of Florida
  • Astellas Pharma US, Inc.
Investigators  ICMJE
Principal Investigator: Michael J Lim, MD St. Louis University
PRS Account St. Louis University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP