The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).
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
TRIPLE
Enrollment
71
0,1mmol/kg at 10 mL/15 sec
same dose as arm 1 at bolus rate (2mL/sec)
0,3mmol/kg at 10 mL/15 sec
Unnamed facility
Miami, Florida, United States
The primary study variable was heart-rate corrected QT (QTc) interval
Time frame: Within 15 min postinjection
Adverse event monitoring, laboratory evaluations
Time frame: 24 hrs postinjection
ECG variables and overall interpretation
Time frame: 24 hrs postinjection
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same dose as arm 3 at bolus rate (2mL/sec)
400 mg at 0,07 mL/sec over 60 min
0,9% saline at 0,6mL/kg at bolus rate