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

Information source: St. Louis University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: adenosine (Drug); regadenoson (Drug); Adenosine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: St. Louis University

Official(s) and/or principal investigator(s):
Michael J Lim, MD, Principal Investigator, Affiliation: St. Louis University

Overall contact:
Michael J Lim, MD, Phone: 314-268-7992, Email: limmj@slu.edu


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.

Clinical Details

Official title: Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Difference in FFR and Coronary Flow Reserve measurements between IV adenosine and IV regadenoson

Secondary outcome: Monitor for potential side effects after IV adenosine and IV regadenoson administration such as chest pain, headache, flushing, nausea or arrhythmias


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Michael J Lim, MD, Phone: 314-268-7992, Email: limmj@slu.edu

University of Florida, Jacksonville, Florida 32209, United States; Recruiting
Martin M Zenni II, MD, Phone: 904-244-3378
Martin M Zenni II, MD, Principal 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, Sub-Investigator

St. Louis University, St. Louis, Missouri 63110, United States; Recruiting
Chris Uhles, RN, Phone: 314-577-8876, Ext: 2, Email: ctaaffe1@slu.edu
Liz Weber, RN, Phone: 314-577-8876, Ext: 3, Email: eweber1@slu.edu
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, Sub-Investigator

Additional Information

Related 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. doi: 10.1056/NEJMoa0807611.

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

Starting date: July 2010
Last updated: November 13, 2012

Page last updated: August 23, 2015

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