Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging (ASSUAGE)
|ClinicalTrials.gov Identifier: NCT01250496|
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).||Drug: Aminophylline Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||November 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
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.
- Composite endpoints of abdominal cramps and diarrhea. [ Time Frame: 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.
- Global symptomatic burden of regadenoson [ Time Frame: within 2 hours from the intervention. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250496
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|