Clinical trial NCT01490294: Myocardial Perfusion MRI
Official title: Multicenter, Double Blind, Randomized Dose Finding Study in Myocardial Perfusion MRI With Gadavist®1.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Perfusion Imaging
Magnetic Resonance Imaging
Keywords: Cardiac MRI
gadobutrol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Secondary outcomes:
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Signal Intensity (SIrel) Based on Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Upslope Based on Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Time to Peak Based on Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes
measure: Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)
timeFrame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
measure: Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
measure: Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)
timeFrame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration
measure: Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
measure: Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)
timeFrame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration
measure: Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)
timeFrame: Immediately within approximately 5 seconds after Gadobutrol bolus administration
Other outcomes:
Locations:
city: Poelten
country: Austria
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Ulm
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Krakow
country: Poland
city: Basel
country: Switzerland
state: Basel-Stadt
city: Lugano
country: Switzerland
state: Ticino
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: