- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370265
Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.
Other Names:
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.
Other Names:
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.
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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.
|
Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.
Other Names:
Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Hyperemic Myocardial Blood Flow (MBF)
Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting Global MBF and Resting Segmental MBF
Time Frame: Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit
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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. |
Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit
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Global Cardiac Flow Rate
Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.
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Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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Hyperemic Segmental MBF
Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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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
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Segmental CFR
Time Frame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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CFR was calculated using the equation: hyperemic MBF/resting MBF.
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Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
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Heart Rate (Beats Per Minute (BPM))
Time Frame: Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit
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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.
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Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit
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Hyperemic Blood Pressure (mmHg)
Time Frame: Day 2, approximately 4 hours after arrival in the PET unit
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Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.
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Day 2, approximately 4 hours after arrival in the PET unit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Panithaya Chareonthaitawee, M.D., Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine A2 Receptor Agonists
- Adenosine
- Regadenoson
Other Study ID Numbers
- 10-006377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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