N/A
N=12
Myocardial Blood Flow by PET and N-13 Ammonia During Regadenoson vs Adenosine Stress
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01370265 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Global Hyperemic Myocardial Blood Flow (MBF) — 3.1; 3.1 mL/min/gm — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Regadenoson (Drug); Adenosine (Drug); N-13 ammonia (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Hyperemic Myocardial Blood Flow (MBF) |
3.1; 3.1 | 0.14 |
| SECONDARY Resting Global MBF and Resting Segmental MBF |
0.8; 0.7; 0.9; 0.8; 0.8 | — |
| SECONDARY Global Cardiac Flow Rate |
3.8; 4.0 | 0.21 |
| SECONDARY Hyperemic Segmental MBF |
2.5; 2.6; 3.1; 3.2; 3.5; 3.6 | 0.57 |
| SECONDARY Segmental CFR |
3.4; 3.7; 3.5; 3.6; 4.4; 4.6 | 0.78 |
| SECONDARY Heart Rate (Beats Per Minute (BPM)) |
62; 60; 98; 93 | 0.28 |
| SECONDARY Hyperemic Blood Pressure (mmHg) |
130; 132; 72; 75 | 0.31 |
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.
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 ( 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
Data sourced from ClinicalTrials.gov (NCT01370265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.