The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
73
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
One intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period 1: Magnevist 0.2 mmol/kg body weightperiod 2: Magnevist 0.1 mmol/kg body weight
Unnamed facility
San Diego, California, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Tulsa, Oklahoma, United States
Unnamed facility
Portland, Oregon, United States
Quantitative measurement of the total area of delayed enhancement
Time frame: 30 min post injection
Quantitative measures of area of delayed enhancement and signal intensities
Time frame: At 5, 10 and 20 minutes post injection
Semiquantitative measures of area of delayed enhancement
Time frame: At 5, 10, 20 and 30 minutes post injection
Presence of delayed enhancement
Time frame: At 5,10 and 20 minutes post injection
Wall motion endpoints
Time frame: Pre-injection
Safety
Time frame: From baseline to 24h follow-up of second imaging
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Hershey, Pennsylvania, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Buenos Aires, Buenos Aires, Argentina