Trial Condition(s):
Myocardial perfusion MRI
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.
- 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
- 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
Locations | Status | ||
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Locations Elisabeth-Krankenhaus Essen, Germany, 45138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Zentralklinikum St. Poelten Poelten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 10115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen, Germany, 32545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Bethanien Krankenhaus Frankfurt, Germany, 60389 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinikum rechts der Isar München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitätsklinikum Ulm Ulm, Germany, 89075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitätsklinikum Freiburg Freiburg, Germany, 79106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Ospedale regionale di Lugano Lugano, Switzerland, CH-6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Szpital Specjalistyczny im. Jana Pawla II Krakow, Poland, 31202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Multicenter, double blind, randomized dose finding study in myocardial perfusion MRI with Gadavist®1.0
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4