Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | November 2010 |
End Date: | September 2011 |
Attenuation of the Side Effect Profile of Regadenoson: A Randomized Double-Blind Placebo Controlled Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging.
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.
(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).
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).
Inclusion Criteria:
- Adult patients referred to undergo a clinically-indicated regadenoson-stress
myocardial perfusion imaging at Rush University Medical Center
Exclusion Criteria:
- Patient refusal to participate
- Known allergic reaction to aminophylline.
- Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea,
abdominal discomfort, nausea or vomiting.
- Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and
acute coronary symptoms.
- Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12
months or any seizure in the past week.
- Pregnant or breast-feeding women.
- Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
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