Myocardial Perfusion MRI

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

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.

Inclusion Criteria:

• Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
• The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Exclusion Criteria:

• Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
• Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
• Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
• Non-sinus rhythm
• Sinus node disease or symptomatic bradycardia
• Second or third degree atrial ventricular (AV) block
• Complete left bundle branch block (LBBB)
• Known congenital long QT syndrome or a family history of congenital long QT syndrome
• Known previous arrhythmias on drugs that prolong cardiac repolarization
• Uncorrected hypokalemia
• Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
• Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
• Ejection fraction below 35%
• Cardiomyopathy, congenital heart defect or higher degree valvular pathology
• Coronary artery stent placement within 4 weeks prior to the MRI procedure
• Previous heart transplantation