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Trial record 8 of 1194 for:    Adenosine

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

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ClinicalTrials.gov Identifier: NCT01161121
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : June 19, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
University of Florida
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Michael J. Lim, St. Louis University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Interventions Drug: adenosine
Drug: regadenoson
Enrollment 46
Recruitment Details Patients provided written consent for participation in the study prior to cardiac catheterization. Diagnostic coronary angiography was performed utilizing standard techniques. Patients in whom the operator believed needed physiologic coronary assessment with Fractional Flow Reserve (FFR) were then eligible for participation in the study.
Pre-assignment Details  
Arm/Group Title Adenosine Then Regadenoson
Hide Arm/Group 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. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.

Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia.

Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush

Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title Adenosine, Regadenoson
Hide Arm/Group Description Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
Patients with intermediate to severe, single vessel or multi-vessel, angiographic coronary artery disease(visual 40%-70% angiographic stenosis) whose lesion assessment with FFR is planned, were eligible for enrollment. A total of up to 50 subjects(25 at University of Florida Health Science Center and 25 at St. Louis University) will be enrolled.
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
39
  84.8%
>=65 years
7
  15.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
59  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
10
  21.7%
Male
36
  78.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title Difference in FFR Between IV Adenosine and IV Regadenoson
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Adenosine Regadenoson
Hide Arm/Group Description:

Adenosine infusion will be compared to Regadenoson for 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 : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia

Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.

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

Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: ratio (Pd/Pa)
0.84  (0.11) 0.84  (0.10)
2.Secondary Outcome
Title Heart Rate Changes With Drug
Hide Description Maximal heart rate documented following the administration of each agent
Time Frame During drug infusion and until restoration of baseline hemodynamics
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine Regadenosine
Hide Arm/Group Description:
With infusion of 140 mcg/kg/min
With bolus infusion of 0.4 mg
Overall Number of Participants Analyzed 46 46
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline Heart Rate 70.8  (11.5) 72.4  (12.0)
Maximal Heart Rate 81.7  (13.4) 90.4  (13.0)
3.Secondary Outcome
Title Side Effects of Medication Administration
Hide Description Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath
Time Frame During drug infusion and until restoration of baseline hemodynamics
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine Regadenoson
Hide Arm/Group Description:

Adenosine infusion will be compared to Regadenoson for 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 : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia

Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.

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

Overall Number of Participants Analyzed 46 46
Measure Type: Number
Unit of Measure: participants
Dyspnea 14 13
Chest Pain 16 13
Any Symptom 27 28
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine Regadenoson
Hide Arm/Group Description

Adenosine infusion will be compared to Regadenoson for 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 : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia

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

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

Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.

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

All-Cause Mortality
Adenosine Regadenoson
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine Regadenoson
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/46 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.17%
Adenosine Regadenoson
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/46 (58.70%)      28/46 (60.87%)    
Cardiac disorders     
Cardiac General -Chest Pain  1  16/46 (34.78%)  16 13/46 (28.26%)  13
Gastrointestinal disorders     
Nausea  1  2/46 (4.35%)  2 5/46 (10.87%)  5
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath  1  14/46 (30.43%)  14 13/46 (28.26%)  13
Skin and subcutaneous tissue disorders     
Flushing  1  6/46 (13.04%)  6 9/46 (19.57%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Lim
Organization: St. Louis University
Phone: 314-268-7992
EMail: limmj@slu.edu
Layout table for additonal information
Responsible Party: Michael J. Lim, St. Louis University
ClinicalTrials.gov Identifier: NCT01161121     History of Changes
Other Study ID Numbers: Rega-9I06
First Submitted: July 6, 2010
First Posted: July 13, 2010
Results First Submitted: July 30, 2013
Results First Posted: June 19, 2017
Last Update Posted: June 23, 2017