drugset / Trial / NCT01490294

Myocardial Perfusion MRI

NCT01490294

Phase 2 Completed 232 enrolled Bayer
RandomizedParallel-groupTriple-blindDiagnostic

Summary

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min. The total imaging time is about 45 min.

Timeline

Start
2004-03
Primary completion
2006-05
Completion
2006-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent 0.01 mmol Intravenous
Subject Gadobutrol Diagnostic / imaging agent 0.025 mmol Intravenous
Subject Gadobutrol Diagnostic / imaging agent 0.05 mmol Intravenous
Subject Gadobutrol Diagnostic / imaging agent 0.1 mmol Intravenous

Indications

No indication recorded.