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

Coronary Artery Disease Clinical Trial

— ASSUAGE-MPI  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01655524
• Other study ID #: ASSUAGE-MPI Trial
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• ASSUAGE Protocol
75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agreement rate in the size of blood flow abnormality category (none/small, moderate or large)	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
Primary	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	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