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Trial record 15 of 1190 for:    Adenosine

Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress

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ClinicalTrials.gov Identifier: NCT01370265
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Panithaya Chareonthaitawee, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Interventions Drug: Regadenoson
Drug: Adenosine
Drug: N-13 ammonia
Enrollment 12
Recruitment Details From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Regadenoson, Then Adenosine Adenosine, Then Regadenoson
Hide Arm/Group Description Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
Period Title: Resting Myocardial Blood Flow (MBF)
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Washout Period (50-minute Period Decay)
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: First Intervention
Started 6 6
Completed 5 5
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Period Title: Washout Period (50-minute Period Decay)
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Second Intervention
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive Regadenoson first and Adenosine first.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
44  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants
26.1  (4.3)
1.Primary Outcome
Title Global Hyperemic Myocardial Blood Flow (MBF)
Hide Description

MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).

The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit.

Time Frame Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mL/min/gm
3.1  (1.4) 3.1  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Resting Global MBF and Resting Segmental MBF
Hide Description

MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).

Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.

Time Frame Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit
Hide Outcome Measure Data
Hide Analysis Population Description
Resting MBF was measured on all subjects prior to the interventions.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Includes groups randomized to receive Regadenoson first and Adenosine first.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ml/min/gm
Resting Global MBF 0.8  (0.2)
Resting Anterior MBF 0.7  (0.2)
Resting Septum MBF 0.9  (0.2)
Resting Inferior MBF 0.8  (0.2)
Resting Lateral MBF 0.8  (0.2)
3.Secondary Outcome
Title Global Cardiac Flow Rate
Hide Description Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.
Time Frame Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ratio
3.8  (1.5) 4.0  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Hyperemic Segmental MBF
Hide Description

Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.

The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.

Time Frame Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mL/min/gm
Hyperemic MBF Anterior 2.5  (0.5) 2.6  (0.8)
Hyperemic MBF Septum 3.1  (0.8) 3.2  (1.4)
Hyperemic MBF Inferior 3.5  (1.6) 3.6  (1.3)
Hyperemic MBF Lateral 2.9  (0.6) 2.9  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Segmental CFR
Hide Description CFR was calculated using the equation: hyperemic MBF/resting MBF.
Time Frame Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ratio
CFR Anterior 3.4  (1.1) 3.7  (1.0)
CFR Septum 3.5  (0.7) 3.6  (1.6)
CFR Inferior 4.4  (1.4) 4.6  (1.3)
CFR Lateral 3.9  (1.0) 4.0  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Heart Rate (Beats Per Minute (BPM))
Hide Description The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
Time Frame Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: bpm
Resting heart rate 62  (10) 60  (9)
Hyperemic heart rate 98  (16) 93  (15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Hyperemic Blood Pressure (mmHg)
Hide Description Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
Time Frame Day 2, approximately 4 hours after arrival in the PET unit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description:
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic 130  (17) 132  (23)
Diastolic 72  (11) 75  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Regadenoson, Adenosine
Comments Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Subjects were monitored for adverse events for the time while on study, approximately 4 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regadenoson Adenosine
Hide Arm/Group Description Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
All-Cause Mortality
Regadenoson Adenosine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Regadenoson Adenosine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regadenoson Adenosine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/12 (8.33%)    
Cardiac disorders     
Ischemic ECG findings   1/12 (8.33%)  1 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Small sample size; Subjects had no evidence of overt coronary artery disease, occult coronary artery disease affecting stress drug induced hyperemic PET MBF is a possibility; however, hyperemic MBF with both stress drugs would be equally affected.
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. Panithaya Chareonthaitawee
Organization: Mayo Clinic
Phone: 507-284-1648
EMail: chareonthaitawee.panithaya@mayo.edu
Layout table for additonal information
Responsible Party: Panithaya Chareonthaitawee, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370265     History of Changes
Other Study ID Numbers: 10-006377
First Submitted: June 6, 2011
First Posted: June 9, 2011
Results First Submitted: October 6, 2012
Results First Posted: September 5, 2013
Last Update Posted: September 5, 2013