Quantification of Myocardial Blood Flow by Positron Emission Tomography and N-13 Ammonia During Regadenoson vs Adenosine Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Global Hyperemic Myocardial Blood Flow (MBF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers over the age of
- •Written informed consent will be obtained from each subject.
- •Each subject will undergo a history and physical examination
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Regadenoson (Drug)
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.
干预措施: Adenosine (Drug)
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.
干预措施: N-13 ammonia (Drug)
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.
干预措施: Regadenoson (Drug)
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.
干预措施: Adenosine (Drug)
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.
干预措施: N-13 ammonia (Drug)
结局指标
主要结局
Global Hyperemic Myocardial Blood Flow (MBF)
时间窗: 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.
次要结局
- Resting Global MBF and Resting Segmental MBF(Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit)
- Global Cardiac Flow Rate(Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit)
- Hyperemic Segmental MBF(Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit)
- Segmental CFR(Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit)
- Heart Rate (Beats Per Minute (BPM))(Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit)
- Hyperemic Blood Pressure (mmHg)(Day 2, approximately 4 hours after arrival in the PET unit)
研究者
Panithaya Chareonthaitawee
Consultant, Associate Professor
Mayo Clinic