The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion

Study Overview
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Brief Summary
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The investigators developed a modified regadenoson nuclear stress test of the heart that incorporates an aminophylline injection following regadenoson (The ASSUAGE protocol). The modified (ASSUAGE) protocol has been associated with fewer side effects and was better tolerated by patients. This study will investigate whether the modified regadenoson stress protocol (ASSUAGE) produces blood flow pattern to the heart similar to that of a standard regadenoson stress protocol. In proven to be the case, the ASSUAGE protocol has the potential to be used on a wide scale instead of the current standard protocol.

Detailed Description
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Patients who had regadenoson stress nuclear stress test of the heart will be invited to return to undergo a modified nuclear stress using the modified (ASSUAGE) protocol. Images from the original scan will be compared to those from the second scan to determine whether the blood flow pattern is similar between the two scans.

Official Title
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The Impact of Routine Administration of Aminophylline Following Regadenoson According to the ASSUAGE Protocol on the Accuracy of Regadenoson Stress Myocardial Perfusion Imaging: A Single-Blinded Cross-Over Clinical Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: ASSUAGE Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test). Exclusion Criteria: inability to provide an informed consent known allergic reaction to aminophylline or regadenoson systolic blood pressure < 90 mmHg unstable abnormal heart rhythm pulmonary edema acute coronary symptoms, myocardial infarction within 48 hours active dipyridamole, aminophylline or theophylline use pregnancy any contraindication to aminophylline according to the drug's package insert: uncontrolled seizure disorder, sepsis with multi-organ failure and liver impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASSUAGE Protocol<br>There is only one arm in this cross-over design trial. Patients who had a standard regadenoson stress test will be invited to enroll in the study. All enrolled subjects will undergo an investigational (ASSUAGE) regadenoson stress test. Imaging scans from the same patients (scan 1 and scan 2) will be compared. | Drug: ASSUAGE Protocol<br>* 75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.<br>* Other names: Aminophylline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Difference Score (SDS); a measure of size and severity of ischemia (heart muscle in jeopardy) detected with regadenoson nuclear stress of the heart (standard vs. ASSUAGE protocol). | The SDS produced with standard protocol will be compared to SDS produced with the modified (ASSUAGE) protocol. The study is set out to demonstrate that there is no significant difference in SDS between the two protocols within the same patients. | The second (investigational) stress will be performed within 4 weeks from the intial one. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement rate in the SDS burden category (normal/mild, moderate or severe) | Agreement rate in the SDS burden category (normal/mild, moderate or severe)between scan 1 and scan 2 will be compared to the agreement rate between 2 sets of images from scan 1. The study is set out to demonstrate that these agreement rates are not significantly different. | within 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)