Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging (ASSUAGE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rami Doukky, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT01250496

First received: November 29, 2010

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 29, 2010
Last Updated Date	November 27, 2012
Start Date ^ICMJE	November 2010
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 29, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01250496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 29, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging
Official Title ^ICMJE	Attenuation of the Side Effect Profile of Regadenoson: A Randomized Double-Blind Placebo Controlled Study With Aminophylline in Patients Undergoing Myocardial Perfusion Imaging.
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).
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson (Lexiscan ®).
Intervention ^ICMJE	Drug: Aminophylline 75 mg of intravenous aminophylline Drug: Placebo Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Study Arm (s)	Experimental: Aminophylline 75 mg of intravenous aminophylline. Intervention: Drug: Aminophylline Placebo Comparator: Placebo Matching normal saline placebo (sterile salt water). Intervention: Drug: Placebo
Publications *	Doukky R, Morales Demori R, Jain S, Kiriakos R, Mwansa V, Calvin JE. Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial". J Nucl Cardiol. 2012 Jun;19(3):448-57. Epub 2012 Mar 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	248
Completion Date	September 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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®).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01250496
Other Study ID Numbers ^ICMJE	ASSUAGETrial
Has Data Monitoring Committee	Yes
Responsible Party	Rami Doukky, Rush University Medical Center
Study Sponsor ^ICMJE	Rush University Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rush University Medical Center
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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