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Trial record 25 of 1194 for:    Adenosine

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

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ClinicalTrials.gov Identifier: NCT01482169
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Robert Bober, M.D., Ochsner Health System

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Intervention Drug: FFR Measurement with IV Adenoscan® then with Regadenoson
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adenoscan + Regadenoson
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Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson

FFR Measurement with IV Adenoscan® then with Regadenoson: 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.

Period Title: Overall Study
Started 48
Completed 46
Not Completed 2
Reason Not Completed
Physician Decision             2
Arm/Group Title Adenoscan + Regadenoson
Hide Arm/Group Description

Subjects will have the FFR Measurement with IV Adenoscan® then with Regadenoson

FFR Measurement with IV Adenoscan® then with Regadenoson: 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.

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  56.5%
>=65 years
20
  43.5%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
61.5  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
9
  19.6%
Male
37
  80.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
 100.0%
1.Primary Outcome
Title Comparing Measurement of Fractional Flow Reserve (FFR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenoscan Regadenoson
Hide Arm/Group Description:

Subjects will have the FFR Measurement with IV Adenoscan®

FFR Measurement with IV Adenoscan®: 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®.

Subjects will have the FFR Measurement with IV Regadenson

FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.

Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: FFR
.83  (0.082) .84  (0.084)
2.Secondary Outcome
Title Duration to Baseline Hyperemia After Aminophylline Injection
Hide Description In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection
Time Frame seconds
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.
Arm/Group Title Duration to Baseline Hyperemia After Aminophylline Administrat
Hide Arm/Group Description:
After subjects have the FFR measurement with Regadenoson, they will be administered aminophylline 150mg IV and the time duration to reach baseline hyperemia will be recorded.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: seconds
112  (72)
Time Frame Subjects were monitored during and post-procedure until discharge from the procedure. This duration was less than 24 hours for each participant.
Adverse Event Reporting Description Definitions do not differ.
 
Arm/Group Title Adenoscan Regadenson
Hide Arm/Group Description

Subjects will have the FFR Measurement with IV Adenoscan®

FFR Measurement with IV Adenoscan®: 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®.

Subjects will have the FFR Measurement with IV Regadenson

FFR Measurement with IV Regadenson: Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive IV Regadenson through a peripheral vein. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved.

All-Cause Mortality
Adenoscan Regadenson
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adenoscan Regadenson
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adenoscan Regadenson
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Bober
Organization: Ochsner Clinic Foundation
Phone: 504-842-4135
EMail: rbober@ochsner.org
Layout table for additonal information
Responsible Party: Robert Bober, M.D., Ochsner Health System
ClinicalTrials.gov Identifier: NCT01482169     History of Changes
Other Study ID Numbers: 10012012
First Submitted: November 15, 2011
First Posted: November 30, 2011
Results First Submitted: April 26, 2017
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018