Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
Conditions
Keywords
regadenoson, lexiscan, aminophylline, SPECT, Myocardial Perfusion Imaging, pharmacologic stress test
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).
Interventions
DRUGAminophylline
75 mg of intravenous aminophylline
DRUGPlacebo
Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoints of Abdominal Cramps and Diarrhea. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects. | within 2 hours from the intervention. | The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at the stress testing laboratories of Rush University Medical Center in the period from November 23, 2010 through February 10, 2011.
Pre-assignment details
Two consenting subjects did not undergo regadenoson-stress for a clinical reason and were subsequently excluded. Otherwise, the remainder of connecting patients received the intervention they are allocated to, completed follow-up and analyzed within the group they were randomized to.
Participants by arm
| Arm | Count |
|---|---|
| Aminophylline 75 mg of intravenous aminophylline. | 124 |
| Placebo Matching normal saline placebo (sterile salt water). | 124 |
| Total | 248 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 124 | 124 |
Baseline characteristics
| Characteristic | Placebo | Aminophylline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 68 Participants | 71 Participants | 139 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 53 Participants | 109 Participants |
| Age, Continuous | 62.0 years STANDARD_DEVIATION 13.6 | 62.4 years STANDARD_DEVIATION 13.1 | 62.2 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 124 participants | 124 participants | 248 participants |
| Sex: Female, Male Female | 54 Participants | 57 Participants | 111 Participants |
| Sex: Female, Male Male | 70 Participants | 67 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 124 |
| other Total, other adverse events | 55 / 124 | 83 / 124 |
| serious Total, serious adverse events | 0 / 124 | 0 / 124 |
Outcome results
Primary
Composite Endpoints of Abdominal Cramps and Diarrhea.
Patients will be surveyed for these symptoms following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory.
Time frame: within 2 hours from the intervention.
Population: All enrolled patients who received the intervention (n=248; 124 aminophylline ans 124 placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aminophylline | Composite Endpoints of Abdominal Cramps and Diarrhea. | 11 Participants |
| Placebo | Composite Endpoints of Abdominal Cramps and Diarrhea. | 22 Participants |
Comparison: null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.p-value: 0.0495% CI: [0.2, 0.98]Chi-squared
Secondary
Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects.
The secondary end-point encompasses any one (or more) regadenoson-related side effects of flushing /feeling hot, chest pain /chest discomfort, angina, headache, dizziness, abdominal cramps/discomfort, diarrhea, and/or nausea. If multiple side effects occur only one side effect is counted.
Time frame: within 2 hours from the intervention.
Population: All enrolled patients who received the intervention (n= 248; 124 aminophyllineand and 124 placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aminophylline | Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects. | 55 participants |
| Placebo | Number of Participants With Composite Endpoint of Any Regadenoson-related Side Effects. | 83 participants |
Comparison: null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison.p-value: <0.00195% CI: [0.2, 0.7]Chi-squared