WithdrawnPhase 4

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

Stopped: Due to nationwide shortage of Aminophylline. No subjects enrolled.

United States0Started 2012-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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).

Timeframe: The second (investigational) stress will be performed within 4 weeks from the intial one.

Trial details

NCT IDNCT01655524

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07