Myocardial Perfusion MRI
Condition: Myocardial Perfusion Imaging; Magnetic Resonance Imaging
Intervention: Gadobutrol (Gadavist,Gadovist, BAY86-4875); Gadobutrol (Gadavist,Gadovist, BAY86-4875); Gadobutrol (Gadavist,Gadovist, BAY86-4875); Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Intervention description: 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); 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); 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); 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)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac MRI; gadobutrol

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.
    

Eligibility criteria:

        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