NCT01490294

Myocardial Perfusion MRI

Multicenter, Double Blind, Randomized Dose Finding Study in Myocardial Perfusion MRI With Gadavist®1.0

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Perfusion Imaging
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadavist,Gadovist, BAY86-4875)	0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)
DRUG	Gadobutrol (Gadavist,Gadovist, BAY86-4875)	0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg)
DRUG	Gadobutrol (Gadavist,Gadovist, BAY86-4875)	0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg)
DRUG	Gadobutrol (Gadavist,Gadovist, BAY86-4875)	0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2011-12-12
• Last updated: 2014-05-22
• Results posted: 2012-06-28

Locations

14 sites across 4 countries: Austria, Germany, Poland, Switzerland