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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

adenosine

regadenoson

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Fractional flow reserve, adenosine, regadenoson

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Florida
St. Louis University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenosine then Regadenoson

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart Rate Changes With Drug

Maximal heart rate documented following the administration of each agent

Side Effects of Medication Administration

Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath

Full Information

NCT ID

NCT01161121

First Posted

July 6, 2010

Last Updated

June 22, 2017

Sponsor

St. Louis University

Collaborators

University of Florida, Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01161121

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Louis University

Collaborators

University of Florida, Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Fractional flow reserve, adenosine, regadenoson

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adenosine then Regadenoson

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

adenosine

Other Intervention Name(s)

Adenoscan(adenosine)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

regadenoson

Other Intervention Name(s)

Lexiscan

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in FFR Between IV Adenosine and IV Regadenoson

Description

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

Time Frame

At maximal, steady-state hyperemia

Secondary Outcome Measure Information:

Title

Heart Rate Changes With Drug

Description

Maximal heart rate documented following the administration of each agent

Time Frame

During drug infusion and until restoration of baseline hemodynamics

Title

Side Effects of Medication Administration

Description

Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath

Time Frame

During drug infusion and until restoration of baseline hemodynamics

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Lim, MD

Organizational Affiliation

St. Louis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

St. Louis University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

7586302

Citation

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.

Results Reference

background

PubMed Identifier

17826318

Citation

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.

Results Reference

background

PubMed Identifier

19144937

Citation

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.

Results Reference

background

PubMed Identifier

16920478

Citation

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.

Results Reference

background

PubMed Identifier

26242981

Citation

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.

Results Reference

derived

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

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