Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Randomized Double-Blind Placebo Controlled Study With Aminophylline to Attenuate the Side Effect Profile of Regadenoson in Patients Undergoing Myocardial Perfusion Imaging.

Conditions
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Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan

Intervention / Treatment
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* Drug: Aminophylline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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®).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminophylline<br>75 mg of intravenous aminophylline. | Drug: Aminophylline<br>* 75 mg of intravenous aminophylline<br>|
| Placebo Comparator: Placebo<br>Matching normal saline placebo (sterile salt water). | Drug: Placebo<br>* Matching 0.9 Normal Saline (sterile salt water)administered intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 2 hours from the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within 2 hours from the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regadenoson, lexiscan, aminophylline, SPECT, Myocardial Perfusion Imaging, pharmacologic stress test