- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655524
The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion (ASSUAGE-MPI)
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
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.
Study Overview
Detailed Description
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: The second (investigational) stress will be performed within 4 weeks from the intial one.
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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.
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The second (investigational) stress will be performed within 4 weeks from the intial one.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement rate in the SDS burden category (normal/mild, moderate or severe)
Time Frame: within 4 weeks
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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.
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within 4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement rate in the size of blood flow abnormality category (none/small, moderate or large)
Time Frame: within 4 weeks
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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.
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within 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rami Doukky, MD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Protective Agents
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Aminophylline
Other Study ID Numbers
- ASSUAGE-MPI Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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