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Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFR Measurement with IV Adenoscan® then with Regadenoson
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing elective left heart catheterization
  • Age ≥ 18 years (female not of child bearing potential)
  • Able to provide written informed consent

Exclusion Criteria:

  • Contraindications to administration of either Adenoscan® or Regadenoson
  • High degree AV block, sick sinus syndrome without a functioning pacemaker
  • Symptomatic bradycardia
  • Recent STEMI (< 5 days)
  • Recent NSTEMI (<5 days) if the peak CK is > 1000 IU
  • Dipyridamole use within 24 hours
  • Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline
  • Known severe bronchoconstrictive lung disease

Sites / Locations

  • Ochsner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adenoscan

Regadenoson

Arm Description

Subjects will have the FFR Measurement with IV Adenoscan®

Subjects will have the FFR Measurement with IV Regadenoson

Outcomes

Primary Outcome Measures

Comparing Measurement of Fractional Flow Reserve (FFR)
For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.

Secondary Outcome Measures

Duration to Baseline Hyperemia After Aminophylline Injection
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection

Full Information

First Posted
November 15, 2011
Last Updated
May 9, 2018
Sponsor
Ochsner Health System
Collaborators
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01482169
Brief Title
Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)
Official Title
Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ochsner Health System
Collaborators
Astellas Pharma Global Development, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.
Detailed Description
This is a prospective open label, single center pilot trial that will evaluate regadenoson compared to Adenoscan® to be given IV in the assessment of Fractional Flow Reserve. Forty eight subjects will be enrolled and get Adenoscan® administered via IV followed by Regadenoson IV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Left heart catheterization, Fractional flow reserve, Adenoscan®, Regadenoson

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenoscan
Arm Type
Active Comparator
Arm Description
Subjects will have the FFR Measurement with IV Adenoscan®
Arm Title
Regadenoson
Arm Type
Experimental
Arm Description
Subjects will have the FFR Measurement with IV Regadenoson
Intervention Type
Drug
Intervention Name(s)
FFR Measurement with IV Adenoscan® then with Regadenoson
Other Intervention Name(s)
Adenoscan® vs Regadenoson
Intervention Description
Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.
Primary Outcome Measure Information:
Title
Comparing Measurement of Fractional Flow Reserve (FFR)
Description
For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.
Time Frame
DAY 1
Secondary Outcome Measure Information:
Title
Duration to Baseline Hyperemia After Aminophylline Injection
Description
In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
Time Frame
seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective left heart catheterization Age ≥ 18 years (female not of child bearing potential) Able to provide written informed consent Exclusion Criteria: Contraindications to administration of either Adenoscan® or Regadenoson High degree AV block, sick sinus syndrome without a functioning pacemaker Symptomatic bradycardia Recent STEMI (< 5 days) Recent NSTEMI (<5 days) if the peak CK is > 1000 IU Dipyridamole use within 24 hours Adenoscan® is contraindicated (hypersensitivity to Adenoscan®, Regadenoson, or aminophylline Known severe bronchoconstrictive lung disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bober, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve (FFR)

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