44
Participants
Start Date
May 16, 2014
Primary Completion Date
January 15, 2017
Study Completion Date
October 23, 2017
regadenoson
Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.
Optimark®
For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.
Myocardial perfusion MRI
Cedars-Sinai Medical Center, Los Angeles
Astellas Pharma US, Inc.
INDUSTRY
Daniel S. Berman
OTHER