Myocardial Perfusion MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01490294
First received: July 28, 2011
Last updated: May 20, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Myocardial Perfusion Imaging
Magnetic Resonance Imaging
Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Multicenter, Double Blind, Randomized Dose Finding Study in Myocardial Perfusion MRI With Gadavist®1.0

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.


Secondary Outcome Measures:
  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

  • Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader.

  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "scar". The number of regional assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

  • Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia".The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by at least 1 blinded reader.

  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by at least 1 blinded reader.

  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia". The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by the investigator.

  • Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by the investigator.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

  • Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

  • Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.

  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • 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) [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

  • Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

  • Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

  • Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

  • Signal Intensity (SIrel) Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated ("normal/diseased" was defined by central reading of SPECT).

  • Upslope Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    "Upslope" is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in "Units/sec". The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference ("normal/diseased" was defined by central reading of SPECT).

  • Time to Peak Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes ] [ Designated as safety issue: No ]
    "Time to peak" is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT).

  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by at least 1 blinded reader.

  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by the investigator.

  • Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

  • Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.

  • 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized

  • 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

  • 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

  • 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

  • Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] [ Designated as safety issue: No ]
    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

  • Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: March 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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)
Experimental: 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.
Drug: 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)
Experimental: 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.
Drug: 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)
Experimental: 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.
Drug: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490294

Locations
Austria
Poelten, Austria, 3100
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Tübingen, Baden-Württemberg, Germany, 72076
Ulm, Baden-Württemberg, Germany, 89075
München, Bayern, Germany, 81377
München, Bayern, Germany, 81675
Frankfurt, Hessen, Germany, 60389
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Bonn, Nordrhein-Westfalen, Germany, 53127
Essen, Nordrhein-Westfalen, Germany, 45138
Berlin, Germany, 10115
Poland
Krakow, Poland, 31202
Switzerland
Basel, Basel-Stadt, Switzerland, 4031
Lugano, Ticino, Switzerland, CH-6900
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01490294     History of Changes
Other Study ID Numbers: 91054, 305501, 2005-005158-32
Study First Received: July 28, 2011
Results First Received: December 23, 2011
Last Updated: May 20, 2014
Health Authority: Germany: Federal Ministry of Education and Research
Austria: Federal Office for Safety in Health Care
Poland: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Bayer:
Cardiac MRI
gadobutrol

Additional relevant MeSH terms:
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014