Regadenoson to Achieve Maximal Hyperemia for Fractional Flow Reserve in the Catheterization Lab - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Adenosine Regadenoson

U.S. FDA Resources

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

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
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

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

Contacts

Contact: Michael J Lim, MD	314-268-7992	limmj@slu.edu
Contact: Joshua Stolker, MD	314-268-5172	jstolker@slu.edu

Locations

United States, Florida
University of Florida	Recruiting
Jacksonville, Florida, United States, 32209
Contact: Martin M Zenni II, MD 904-244-3378
Principal Investigator: Martin M Zenni II, MD
Sub-Investigator: Bharat Gummadi, MD
Sub-Investigator: Dominick Angiolillo, MD PhD
Sub-Investigator: Lyndon Box, MD
Sub-Investigator: Luis Guzman, MD
Sub-Investigator: Theodore Bass, MD
United States, Missouri
St. Louis University	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Chris Uhles, RN 314-577-8876 ext 2 ctaaffe1@slu.edu
Contact: Liz Weber, RN 314-577-8876 ext 3 eweber1@slu.edu
Sub-Investigator: Joshua Stolker, MD
Sub-Investigator: Robert Neumayr, MD
Sub-Investigator: Bryan Piotrowski, MD
Sub-Investigator: Robert Armbruster, MD
Sub-Investigator: Zainal Hussain, MD
Sub-Investigator: Steven Rough, MD

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:

Pijls NH, Van Gelder B, Van der Voort P, Peels K, Bracke FA, Bonnier HJ, el Gamal MI. Fractional flow reserve. A useful index to evaluate the influence of an epicardial coronary stenosis on myocardial blood flow. Circulation. 1995 Dec 1;92(11):3183-93.

Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58.

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24.

Lim MJ, Kern MJ. Coronary pathophysiology in the cardiac catheterization laboratory. Curr Probl Cardiol. 2006 Aug;31(8):493-550. Review.

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013