The Impact of the Routine Aminophylline Administration Following Regadenoson Stress on SPECT Myocardial Perfusion (ASSUAGE-MPI)

This study has suspended participant recruitment.
(Due to nationwide shortage of Aminophylline.)
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01655524
First received: July 26, 2012
Last updated: March 14, 2014
Last verified: July 2012
  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 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655524

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
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: March 14, 2014
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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cardiotonic Agents
Cardiovascular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists

ClinicalTrials.gov processed this record on August 28, 2014