Study With Aminophylline to Attenuate of the Side Effects of Regadenoson

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aminophylline

75 mg of intravenous aminophylline.

Group Type EXPERIMENTAL

Aminophylline

Intervention Type DRUG

75 mg of intravenous aminophylline

Placebo

Matching normal saline placebo (sterile salt water).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Interventions

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Aminophylline

75 mg of intravenous aminophylline

Intervention Type DRUG

Placebo

Matching 0.9 Normal Saline (sterile salt water)administered intravenously.

Intervention Type DRUG

Eligibility Criteria

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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®).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No