The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion (ASSUAGE-MPI)
This study is currently recruiting participants.
Verified July 2012 by Rush University Medical Center
Sponsor:
Rush University Medical Center
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01655524
First received: July 26, 2012
Last updated: July 30, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: ASSUAGE Protocol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Rush University Medical Center:
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). [ Time Frame: The second (investigational) stress will be performed within 4 weeks from the intial one. ] [ Designated as safety issue: No ]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) [ Time Frame: within 4 weeks ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Agreement rate in the size of blood flow abnormality category (none/small, moderate or large) [ Time Frame: within 4 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ASSUAGE Protocol
There is only one arm in this cross-over design trial. Patients who had a standard regadenson stress test will be invited to enroll in the study. All enrolled subjects will undergo an investigational (ASSUAGE) regadenson stress test. Imaging scans from the same patients (scan 1 and scan 2) will be compared.
|
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.
Other Name: Aminophylline
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655524
Contacts
| Contact: Rami Doukky, MD | 312-942-4655 | rami_doukky@rush.edu |
Locations
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Rami Doukky, MD 312-942-4655 rami_doukky@rush.edu | |
| Principal Investigator: Rami Doukky, MD | |
Sponsors and Collaborators
Rush University Medical Center
Investigators
| Principal Investigator: | Rami Doukky, MD | Rush University Medical Center |
More Information
No publications provided
| Responsible Party: | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01655524 History of Changes |
| Other Study ID Numbers: | ASSUAGE-MPI Trial |
| Study First Received: | July 26, 2012 |
| Last Updated: | July 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Rush University Medical Center:
|
Regadenoson Aminophylline ASSUAGE Myocardial Perfusion Imaging (MPI) |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aminophylline Regadenoson Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Protective Agents Adenosine A2 Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013