Status:
COMPLETED
Myocardial Perfusion MRI
Lead Sponsor:
Bayer
Conditions:
Myocardial Perfusion Imaging
Magnetic Resonance Imaging
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT01490294
Start Date
March 1 2004
End Date
May 1 2006
Last Update
May 22 2014
Active Locations (14)
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1
Pölten, Austria, 3100
2
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
3
Tübingen, Baden-Wurttemberg, Germany, 72076
4
Ulm, Baden-Wurttemberg, Germany, 89075