Myocardial Perfusion MRI

Bayer

Status and phase: Completed; Phase 2

Conditions: Myocardial Perfusion Imaging; Magnetic Resonance Imaging

Treatments: Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490294

305501 (Other Identifier)

2005-005158-32 (EudraCT Number)

91054

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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232 participants in 4 patient groups

Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

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.

Treatment:

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

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.

Treatment:

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

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.

Treatment:

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)

Experimental group

Description:

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.

Treatment:

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)