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

NCT01161121 | Completed Phase 1 Results DMC

• 1 other identifier: Rega-9I06
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

Fractional flow reserve; adenosine; regadenoson

Outcome Measures

Primary Outcomes (1)

• Difference in FFR Between IV Adenosine and IV Regadenoson

  FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson

  At maximal, steady-state hyperemia

Secondary Outcomes (2)

• Heart Rate Changes With Drug

  During drug infusion and until restoration of baseline hemodynamics

• Side Effects of Medication Administration

  During drug infusion and until restoration of baseline hemodynamics

Study Arms (1)

Adenosine then Regadenoson

EXPERIMENTAL

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; Drug: regadenoson

Interventions

adenosine DRUG

Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.

Also known as: Adenoscan(adenosine)

Adenosine then Regadenoson

regadenoson DRUG

Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.

Also known as: Lexiscan

Adenosine then Regadenoson

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• University of Florida: collaborator
• Astellas Pharma US, Inc.: collaborator

Study Sites (2)

University of Florida

Jacksonville, Florida, 32209, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• 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. doi: 10.1161/01.cir.92.11.3183.

  PMID: 7586302 BACKGROUND

• 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. doi: 10.1016/j.nuclcard.2007.06.114.

  PMID: 17826318 BACKGROUND

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom 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.

  PMID: 19144937 BACKGROUND

• Lim MJ, Kern MJ. Coronary pathophysiology in the cardiac catheterization laboratory. Curr Probl Cardiol. 2006 Aug;31(8):493-550. doi: 10.1016/j.cpcardiol.2006.04.002.

  PMID: 16920478 BACKGROUND

• Stolker JM, Lim MJ, Shavelle DM, Morris DL, Angiolillo DJ, Guzman LA, Kennedy KF, Weber E, Zareh M, Neumayr RH, Zenni MM. Pooled comparison of regadenoson versus adenosine for measuring fractional flow reserve and coronary flow in the catheterization laboratory. Cardiovasc Revasc Med. 2015 Jul-Aug;16(5):266-71. doi: 10.1016/j.carrev.2015.05.011. Epub 2015 Jun 5.

  PMID: 26242981 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Adenosine; regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Michael Lim
• Organization: St. Louis University

limmj@slu.edu

314-268-7992

Study Officials

• Michael J Lim, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Cardiology

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 23, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)