The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.
Approximately 250 patients who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a matching inactive placebo (sterile salt water) injection. Participants will be surveyed for gastrointestinal symptoms and other side effects related to regadenoson. The frequency and severity of such side effects will be compared between the two study groups (aminophylline vs. placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
248
75 mg of intravenous aminophylline
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Rush University Medical Center
Chicago, Illinois, United States
Composite Endpoints of Abdominal Cramps and Diarrhea.
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
Time frame: within 2 hours from the intervention.
"Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.
The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted.
Time frame: within 2 hours from the intervention.
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