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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson, then Adenosine | Active Comparator | 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, then Regadenoson | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Hyperemic Myocardial Blood Flow (MBF) | 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. | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Global MBF and Resting Segmental MBF | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panithaya Chareonthaitawee, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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From June 30 to December 27, 2011 subjects were recruited at Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Resting Myocardial Blood Flow (MBF) |
| |||||||||||||
| Washout Period (50-minute Period Decay) |
| |||||||||||||
| First Intervention |
| |||||||||||||
| Washout Period (50-minute Period Decay) |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Regadenoson first and Adenosine first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Hyperemic Myocardial Blood Flow (MBF) | 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. | 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. | Posted | Mean | Standard Deviation | mL/min/gm | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
|
Subjects were monitored for adverse events for the time while on study, approximately 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regadenoson | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic ECG findings | Cardiac disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Panithaya Chareonthaitawee | Mayo Clinic | 507-284-1648 | chareonthaitawee.panithaya@mayo.edu |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Adenosine | Drug | Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. |
|
|
| N-13 ammonia | Drug | 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. |
|
| Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit |
| Global Cardiac Flow Rate | Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF. | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
| Hyperemic Segmental MBF | 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. | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
| Segmental CFR | CFR was calculated using the equation: hyperemic MBF/resting MBF. | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
| Heart Rate (Beats Per Minute (BPM)) | 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. | Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit |
| Hyperemic Blood Pressure (mmHg) | Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization. | Day 2, approximately 4 hours after arrival in the PET unit |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Adenosine | 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. |
|
|
|
| Secondary | Resting Global MBF and Resting Segmental MBF | 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. | Resting MBF was measured on all subjects prior to the interventions. | Posted | Mean | Standard Deviation | ml/min/gm | Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit |
|
|
|
| Secondary | Global Cardiac Flow Rate | Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF. | 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. | Posted | Mean | Standard Deviation | ratio | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
|
|
|
|
| Secondary | Hyperemic Segmental MBF | 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. | 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. | Posted | Mean | Standard Deviation | mL/min/gm | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
|
|
|
|
| Secondary | Segmental CFR | CFR was calculated using the equation: hyperemic MBF/resting MBF. | 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. | Posted | Mean | Standard Deviation | ratio | Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit |
|
|
|
|
| Secondary | Heart Rate (Beats Per Minute (BPM)) | 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. | 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. | Posted | Mean | Standard Deviation | bpm | Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit |
|
|
|
|
| Secondary | Hyperemic Blood Pressure (mmHg) | Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization. | 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. | Posted | Mean | Standard Deviation | mmHg | Day 2, approximately 4 hours after arrival in the PET unit |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Adenosine | 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. | 0 | 12 | 1 | 12 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| Title | Measurements |
|---|---|
|
| Resting Inferior MBF |
|
| Resting Lateral MBF |
|
| Hyperemic MBF Inferior |
|
| Hyperemic MBF Lateral |
|
| t-test, 2 sided |
| 0.13 |
| 95 |
| No |
| Superiority or Other |
| Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05. | t-test, 2 sided | 0.44 | 95 | No | Superiority or Other |
| Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05. | t-test, 2 sided | 0.74 | 95 | No | Superiority or Other |
| CFR Inferior |
|
| CFR Lateral |
|
| t-test, 2 sided |
| 0.42 |
| 95 |
| No |
| Superiority or Other |
| Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05 | t-test, 2 sided | 0.96 | 95 | No | Superiority or Other |
| Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05. | t-test, 2 sided | 0.13 | 95 | No | Superiority or Other |
| t-test, 2 sided |
| 0.51 |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided |
| 0.08 |
| 95 |
| No |
| Superiority or Other |