Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

Phase 4

Terminated

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

Brief Summary: 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: 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).

Recruitment & Eligibility

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®).

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching normal saline placebo (sterile salt water).
Aminophylline	Aminophylline	75 mg of intravenous aminophylline.

Primary Outcome Measures

Name	Time	Method
Composite Endpoints of Abdominal Cramps and Diarrhea.	within 2 hours from the intervention.	Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.

Secondary Outcome Measures

Name	Time	Method
"Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.	within 2 hours from the intervention.	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.