Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging (ASSUAGE)
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.
Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Attenuation of the Side Effect Profile of Regadenoson: A Randomized Double-Blind Placebo Controlled Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging.|
- Composite endpoints of abdominal cramps and diarrhea. [ Time Frame: within 2 hours from the intervention. ] [ Designated as safety issue: No ]Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
- Global symptomatic burden of regadenoson [ Time Frame: within 2 hours from the intervention. ] [ Designated as safety issue: No ]Secondary end-point encompasses the sum of all regadenoson-related adverse-events of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea, bronchospasm and the need to administer a clinically indicated aminophylline to treat suspected regadenoson related side effects.
|Study Start Date:||November 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
75 mg of intravenous aminophylline.
75 mg of intravenous aminophylline
Placebo Comparator: Placebo
Matching normal saline placebo (sterile salt water).
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250496
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|