Coronary Artery DiseaseNCT01370265
Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
A study testing Regadenoson, Adenosine and N-13 ammonia in people with Coronary Artery Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Regadenoson, Adenosine and N-13 ammonia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Regadenoson, Adenosine, N-13 ammonia
- Keywords
- Regadenoson (Lexiscan), PET N-13 ammonia imaging, Myocardial Blood Flow (MBF), Regadenoson Stress
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegadenosonDrug
Also called Lexiscan
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.
AdenosineDrug
Also called Adenoscan
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.
N-13 ammoniaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Regadenoson; Drug: Adenosine; Drug: N-13 ammonia |
| 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. Receives: Drug: Regadenoson; Drug: Adenosine; Drug: N-13 ammonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 2, approximately 4 hours after arrival in the PET unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Panithaya Chareonthaitawee, Mayo Clinic
- Investigators
- Panithaya Chareonthaitawee, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370265
- Sponsor's protocol ID
- 10-006377
- Status last verified
- Sep 2013
- First submitted
- 6 Jun 2011
- Last updated
- 5 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
- ClinicalTrials.gov ID
- NCT01370265
- Acronym / sponsor ID
- 10-006377
- Conditions
- Coronary Artery Disease
- Keywords
- Regadenoson (Lexiscan), PET N-13 ammonia imaging, Myocardial Blood Flow (MBF), Regadenoson Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 5 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regadenoson, then Adenosine | Active comparator | Drug: Regadenoson, Drug: Adenosine, Drug: N-13 ammoniaRegadenoson (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 | Drug: Regadenoson, Drug: Adenosine, Drug: N-13 ammoniaAdenosine (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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegadenosonAlso: LexiscanRegadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush. | Drug | Adenosine, then Regadenoson, Regadenoson, then Adenosine |
| AdenosineAlso: AdenoscanAdenosine (140 μg/kg/min) was administered intravenously over 6 minutes. | Drug | Adenosine, then Regadenoson, Regadenoson, then Adenosine |
| N-13 ammoniaAmmonia 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. | Drug | Adenosine, then Regadenoson, Regadenoson, then Adenosine |
Primary outcome
Global Hyperemic Myocardial Blood Flow (MBF)
Time frame: 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.
6 secondary outcomes
Resting Global MBF and Resting Segmental MBF
Time frame: Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit
Global Cardiac Flow Rate
Time frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Hyperemic Segmental MBF
Time frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Segmental CFR
Time frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Heart Rate (Beats Per Minute (BPM))
Time frame: Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit
Hyperemic Blood Pressure (mmHg)
Time frame: Day 2, approximately 4 hours after arrival in the PET unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panithaya Chareonthaitawee, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regadenoson, Adenosine and N-13 ammonia in people with Coronary Artery Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Hyperemic Myocardial Blood Flow (MBF) (time frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.