Coronary Artery Disease
Conditions
Keywords
Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)
Brief summary
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
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.
Interventions
DRUGASSUAGE Protocol
75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 second (investigational) stress will be performed within 4 weeks from the intial one. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement rate in the SDS burden category (normal/mild, moderate or severe) | within 4 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Agreement rate in the size of blood flow abnormality category (none/small, moderate or large) | within 4 weeks | 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. |
Countries
United States
Outcome results
None listed