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

Phase 4

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: ASSUAGE Protocol

• Registration Number: NCT01655524
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-08-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASSUAGE Protocol	ASSUAGE Protocol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States