Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson Stress
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Purpose
The investigators propose to measure and compare regadenoson-induced hyperemic Myocardial Blood Flow (MBF) versus adenosine-induced hyperemic MBF, using PET N-13 Ammonia in healthy subjects. The protocol will provide clinically useful data for practice.
| Condition | Intervention |
|---|---|
|
Regadenoson Stress |
Drug: Regadenoson Drug: Adenosine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson Stress |
- Myocardial blood flow (MBF) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]To quantify regadenoson-induced hyperemic PET N-13 ammonia MBF and compare to adenosine-induced hyperemic PET N-13 ammonia MBF.
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Regadenoson
To Assess Regadenoson stress PET N-13 Ammonia MBF.
|
Drug: Regadenoson
regadenoson (0.4 mg/5 ml IV) will be administered intravenously over 10 seconds, followed immediately by saline flush
Other Name: Lexiscan
|
|
Active Comparator: Adenosine
To assess adenosine stress PET N-13 Ammonia MBF
|
Drug: Adenosine
adenosine (140 μg/kg/min) will be administered intravenously over 6 minutes
Other Name: Adenoscan
|
Detailed Description:
Growing clinical experience and published studies support the comparable diagnostic accuracy, safety, and better subjective tolerability of regadenoson as compared to adenosine. Furthermore, while dipyridamole and adenosine are contraindicated in patients with asthma and significant chronic obstructive pulmonary disease (COPD), pilot data suggest overall safety of regadenoson in patients with mild or moderate asthma and in patients with stable moderate COPD.
The use of the cyclotron-produced and FDA-approved PET perfusion tracer, N-13 ammonia, with regadenoson has not been published. Among the nuclear perfusion tracers, N-13 ammonia provides the best image quality, high diagnostic accuracy, and the lowest total body radiation exposure. Quantification of myocardial blood flow (MBF) in ml per min per gm is also possible with N-13 ammonia, adding clinically useful information and powerful prognostic value and is increasingly utilized in clinical practice. In studies of PET with N-13 ammonia, MBF increases up to four-fold with adenosine or dipyridamole in healthy human volunteers and normal myocardium. However, the PET acquisition protocol for N-13 ammonia with regadenoson stress and the limits of normal PET measured hyperemic blood flow after regadenoson infusion have not been published. The optimal timing of N-13 ammonia administration and of PET image acquisition as well as acquisition duration following regadenoson bolus is not known. Different physical and biological properties of PET perfusion tracers necessitate specific protocols for each tracer.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Twelve 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, NSAIDs, and thyroid hormone replacement)
- Illicit drug use
- Prior allergic reaction to adenosine, regadenoson, or aminophylline
- Pregnancy
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Panithaya Chareonthaitawee M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01370265 History of Changes |
| Other Study ID Numbers: | 10-006377 |
| Study First Received: | June 6, 2011 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
Regadenoson (Lexiscan) PET N-13 ammonia imaging Myocardial Blood Flow (MBF) Regadenoson Stress |
Additional relevant MeSH terms:
|
Adenosine Regadenoson Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013