Trial Condition(s):

Myocardial Perfusion Imaging, Magnetic Resonance Imaging

Myocardial perfusion MRI

Bayer Identifier:

91054

ClinicalTrials.gov Identifier:

NCT01490294

EudraCT Number:

2005-005158-32

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
232
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Elisabeth-Krankenhaus

Essen, Germany, 45138

Status
Completed
 
Locations

Zentralklinikum St. Poelten

Poelten, Austria, 3100

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 10115

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany, 32545

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53127

Status
Completed
 
Locations

Bethanien Krankenhaus

Frankfurt, Germany, 60389

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Freiburg

Freiburg, Germany, 79106

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, CH-6900

Status
Completed
 
Locations

Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland, 31202

Status
Completed
 

Trial Design