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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01370265
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Blockage of the heart arteries (coronary artery disease) can lead to angina (chest pain), heart attacks, heart failure, and/or death. Positron emission tomography (PET) stress myocardial perfusion imaging (MPI) is a powerful tool to help identify blockages in the coronary arteries. During the PET MPI test, a drug is given to mimic the effects of exercise on the heart. The study was done to measure blood flow to the heart using two similar drugs approved to mimic the effects of exercise on the heart in people during a heart stress test. The first drug, called adenosine, has been approved for this use for several decades. The second drug, called regadenoson, was approved in 2008. The investigators were looking at whether the increase in blood flow to the heart with the newer drug (regadenoson) was similar to the increase in blood flow with the older drug (adenosine). This information is important for the use of these drugs in patients and for interpreting the blood flow values.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Regadenoson; Drug: Adenosine; Drug: N-13 ammonia	N/A

Detailed Description

The hypothesis for this study was that Regadenoson will produce a very similar degree of maximal hyperemia (increased blood flow) as adenosine, the other vasodilator agent. There were only 2 days on study for each subject.

On Day 1 of the study, subjects were interviewed and had a physical exam, including a resting 12-lead electrocardiogram (ECG) to exclude evidence of silent ischemia or myocardial infarction, and other cardiovascular disorders. Subjects were instructed to have a light meal at least 4 hours prior to the PET MPI. Subjects were instructed to abstain from caffeine-containing products for 24 hours prior to the PET scan. Day 1 of the study occurred less than or equal to 4 weeks of Day 2.

On Day 2 of the study, each subject underwent three PET N-13 ammonia (10-20 mCi) dynamic emission acquisitions: resting, regadenoson (0.4 mg/5 mL IV), and adenosine (140 microgram/kg/min; order of regadenoson vs adenosine was randomized according to subject's birth year), and three transmission acquisitions for attenuation correction. Each emission acquisition was separated by 50 min to allow for radioactive decay. At the end of the drug infusions, subjects were monitored for 5-30 min. Based on the known short biological half-lives of these stress agents, the pharmacologic effects of each drug should have dissipated by the time the next drug was administered.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Regadenoson, then Adenosine 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.	Drug: Regadenoson; Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.; Other Names: Lexiscan ; Drug: Adenosine; Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.; Other Names: Adenoscan ; Drug: N-13 ammonia; Ammonia N-13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. The N-13 ammonia used in the study was synthesized by the Mayo Cyclotron Facility as per routine institutional clinical protocol.
Active Comparator: Adenosine, then Regadenoson 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.	Drug: Regadenoson; Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.; Other Names: Lexiscan ; Drug: Adenosine; Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.; Other Names: Adenoscan ; Drug: N-13 ammonia; Ammonia N-13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. The N-13 ammonia used in the study was synthesized by the Mayo Cyclotron Facility as per routine institutional clinical protocol.

Outcome Measures

Primary Outcome Measures

1. Global Hyperemic Myocardial Blood Flow (MBF) [Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit]

   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.

Secondary Outcome Measures

1. Resting Global MBF and Resting Segmental MBF [Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit]

   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.

2. Global Cardiac Flow Rate [Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit]

   Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.

3. Hyperemic Segmental MBF [Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit]

   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.

4. Segmental CFR [Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit]

   CFR was calculated using the equation: hyperemic MBF/resting MBF.

5. Heart Rate (Beats Per Minute (BPM)) [Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit]

   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.

6. Hyperemic Blood Pressure (mmHg) [Day 2, approximately 4 hours after arrival in the PET unit]

   Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and female volunteers over the age of 30.

• Written informed consent will be obtained from each subject.

• Each subject will undergo a history and physical examination

Exclusion Criteria:

• Any cardiovascular or pulmonary symptoms or exam findings

• History of low blood pressure (< 90/50 mmHg)

• Prior cardiac history

• History of hypertension

• History of hyperlipidemia

• History of diabetes mellitus

• History of asthma or chronic obstructive pulmonary disease

• Weight of > 450 pounds

• Chronic kidney disease

• Other serious illness such as cancer

• Current smoking

• Medication use (with the exception of acetaminophen, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and thyroid hormone replacement)

• Illicit drug use

• Prior allergic reaction to adenosine, regadenoson, or aminophylline

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Astellas Pharma Inc

Investigators

• Principal Investigator: Panithaya Chareonthaitawee, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Panithaya Chareonthaitawee, Consultant, Associate Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01370265
• Other Study ID Numbers: 10-006377
• First Posted: Jun 9, 2011
• Last Update Posted: Sep 5, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Panithaya Chareonthaitawee, Consultant, Associate Professor, Mayo Clinic: Regadenoson (Lexiscan); PET N-13 ammonia imaging; Myocardial Blood Flow (MBF); Regadenoson Stress
• Additional relevant MeSH terms: Coronary Artery Disease; Adenosine; Regadenoson

Study Results

Participant Flow

Recruitment Details	From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.

Arm/Group Title	Regadenoson, Then Adenosine	Adenosine, Then Regadenoson
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: Resting Myocardial Blood Flow (MBF)
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0
Period Title: Resting Myocardial Blood Flow (MBF)
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1
Period Title: Resting Myocardial Blood Flow (MBF)
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0
Period Title: Resting Myocardial Blood Flow (MBF)
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes groups randomized to receive Regadenoson first and Adenosine first.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (8)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.1 (4.3)

Outcome Measures

1. Primary Outcome

Title	Global Hyperemic Myocardial Blood Flow (MBF)
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

Outcome Measure Data

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
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.
Measure Participants	10	10
Mean (Standard Deviation) [mL/min/gm]	3.1 (1.4)	3.1 (1.2)

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
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Resting Global MBF and Resting Segmental MBF
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

Outcome Measure Data

Analysis Population Description

Resting MBF was measured on all subjects prior to the interventions.

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes groups randomized to receive Regadenoson first and Adenosine first.
Measure Participants	10
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
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

Outcome Measure Data

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
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.
Measure Participants	10	10
Mean (Standard Deviation) [ratio]	3.8 (1.5)	4.0 (1.4)

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
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Hyperemic Segmental MBF
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

Outcome Measure Data

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
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.
Measure Participants	10	10
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)

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
Statistical Test of Hypothesis	p-Value	0.57
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.74
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Segmental CFR
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

Outcome Measure Data

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
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.
Measure Participants	10	10
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)

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
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Heart Rate (Beats Per Minute (BPM))
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

Outcome Measure Data

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
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.
Measure Participants	10	10
Resting heart rate	62 (10)	60 (9)
Hyperemic heart rate	98 (16)	93 (15)

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
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Hyperemic Blood Pressure (mmHg)
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

Outcome Measure Data

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
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.
Measure Participants	10	10
Systolic	130 (17)	132 (23)
Diastolic	72 (11)	75 (17)

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
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	t-test, 2 sided
	Comments

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
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Subjects were monitored for adverse events for the time while on study, approximately 4 weeks.
Arm/Group Title	Regadenoson		Adenosine
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Regadenoson		Adenosine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Regadenoson		Adenosine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		1/12 (8.3%)
Cardiac disorders
Ischemic ECG findings	1/12 (8.3%)	1	1/12 (8.3%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.