Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
232 participants
INTERVENTIONAL
2004-03-31
2006-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)
Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)
Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)
Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)
Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Interventions
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Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
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)
Eligibility Criteria
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Inclusion Criteria
* The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Pölten, , Austria
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Berlin, , Germany
Krakow, , Poland
Basel, Canton of Basel-City, Switzerland
Lugano, Canton Ticino, Switzerland
Countries
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Other Identifiers
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305501
Identifier Type: OTHER
Identifier Source: secondary_id
2005-005158-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91054
Identifier Type: -
Identifier Source: org_study_id
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