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Regadenoson to Achieve Maximal Hyperemia for Fractional Flow Reserve in the Catheterization Lab

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by St. Louis University.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
University of Florida
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Michael J. Lim, St. Louis University
ClinicalTrials.gov Identifier:
NCT01161121
First received: July 6, 2010
Last updated: November 13, 2012
Last verified: November 2012
  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
Drug: Adenosine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 St. Louis University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adenosine
Adenosine infusion will be compared to Regadenoson for 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.
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
Drug: Adenosine
Injection of IV Adenosine for 2 minutes at rate of 140mg/kg to dilate coronary arteries and provoke maximal hyperemia
Active Comparator: Regadenoson
Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.
Drug: regadenoson
Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
Other Name: Lexiscan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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 B-HCG pregnancy test within 24 hours prior to enrollment.
  • Provided written consent approved by Institutional Review Board and provided 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161121

Locations
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
United States, Missouri
St. Louis University
St. 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 
Study First Received: July 6, 2010
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on December 07, 2016