Back to resultsThe Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion (ASSUAGE-MPI)
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ASSUAGE Protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)
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
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASSUAGE Protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01655524
First Posted
July 26, 2012
Last Updated
October 4, 2021
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01655524
Brief Title
The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to nationwide shortage of Aminophylline. No subjects enrolled.
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Regadenoson, Aminophylline, ASSUAGE, Myocardial Perfusion Imaging (MPI)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASSUAGE Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ASSUAGE Protocol
Other Intervention Name(s)
Aminophylline
Intervention Description
75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
The second (investigational) stress will be performed within 4 weeks from the intial one.
Secondary Outcome Measure Information:
Title
Agreement rate in the SDS burden category (normal/mild, moderate or severe)
Description
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.
Time Frame
within 4 weeks
Other Pre-specified Outcome Measures:
Title
Agreement rate in the size of blood flow abnormality category (none/small, moderate or large)
Description
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.
Time Frame
within 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Doukky, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion
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