Clinical trial NCT01370265: Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Official title: Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Regadenoson (Lexiscan)
PET N-13 ammonia imaging
Myocardial Blood Flow (MBF)
Regadenoson Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2011-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global Hyperemic Myocardial Blood Flow (MBF)
timeFrame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
Secondary outcomes:
measure: Resting Global MBF and Resting Segmental MBF
timeFrame: Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit
measure: Global Cardiac Flow Rate
timeFrame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
measure: Hyperemic Segmental MBF
timeFrame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
measure: Segmental CFR
timeFrame: Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit
measure: Heart Rate (Beats Per Minute (BPM))
timeFrame: Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit
measure: Hyperemic Blood Pressure (mmHg)
timeFrame: Day 2, approximately 4 hours after arrival in the PET unit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Panithaya Chareonthaitawee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: