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

NCT01655524 | Withdrawn Phase 4 DMC

• 1 other identifier: ASSUAGE-MPI Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Regadenoson; Aminophylline; ASSUAGE; Myocardial Perfusion Imaging (MPI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agreement rate in the SDS burden category (normal/mild, moderate or severe)

  within 4 weeks

Other Outcomes (1)

• Agreement rate in the size of blood flow abnormality category (none/small, moderate or large)

  within 4 weeks

Study Arms (1)

ASSUAGE Protocol

EXPERIMENTAL

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

Interventions

ASSUAGE Protocol DRUG

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

Also known as: Aminophylline

ASSUAGE Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have had a qualifying regadenoson stress myocardial perfusion imaging (regadenoson nuclear stress test).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aminophylline

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Rami Doukky, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

US (1)