Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging (ASSUAGE)
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|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|
|Actual Primary Completion Date :||September 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|