Clinical trial NCT01655524: The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Regadenoson
Aminophylline
ASSUAGE
Myocardial Perfusion Imaging (MPI)
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: The second (investigational) stress will be performed within 4 weeks from the intial one.
Secondary outcomes:
measure: Agreement rate in the SDS burden category (normal/mild, moderate or severe)
timeFrame: within 4 weeks
Other outcomes:
measure: Agreement rate in the size of blood flow abnormality category (none/small, moderate or large)
timeFrame: within 4 weeks
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Rami Doukky, MD
role: PRINCIPAL_INVESTIGATOR
References: