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

Rush

Status and phase: Withdrawn; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: ASSUAGE Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01655524

ASSUAGE-MPI Trial

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 1 patient group

ASSUAGE Protocol

Experimental group

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.

Treatment:

Drug: ASSUAGE Protocol