Clinical trial NCT01250496: Study With Aminophylline to Attenuate of the Side Effects of Regadenoson
Official title: A Randomized Double-Blind Placebo Controlled Study With Aminophylline to Attenuate the Side Effect Profile of Regadenoson in Patients Undergoing Myocardial Perfusion Imaging.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Keywords: regadenoson
lexiscan
aminophylline
SPECT
Myocardial Perfusion Imaging
pharmacologic stress test
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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®).

Primary outcomes:
measure: Composite Endpoints of Abdominal Cramps and Diarrhea.
timeFrame: within 2 hours from the intervention.
Secondary outcomes:
measure: "Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.
timeFrame: within 2 hours from the intervention.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: 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. doi: 10.1007/s12350-012-9533-x. Epub 2012 Mar 7.
citation: Ballany W, Mansour K, Morales Demori R, Al-Amoodi M, Doukky R. The impact of regimented aminophylline use on extracardiac radioisotope activity in patients undergoing regadenoson stress SPECT myocardial perfusion imaging: a substudy of the ASSUAGE trial. J Nucl Cardiol. 2014 Jun;21(3):496-502. doi: 10.1007/s12350-014-9864-x. Epub 2014 Feb 12.