| Primary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment | Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR, coronary angiography [CA] or computed tomography angiography [CTA, only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). | Participants in FAS (full analysis set, included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
| | | Title | Denominators | Categories |
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| Reader 1 | | | | Reader 2 | | | | Reader 3 | | |
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| Primary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' Assessment | Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Primary | Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment | Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Primary | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' Assessment | Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Primary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
| |
| Primary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment | The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
| |
| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment | The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
|
| Secondary | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment | The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
| |
| Secondary | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment | The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
|
| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
| |
| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment | Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment | Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT. | Posted | | Number | | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment | Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT. | Posted | | Number | | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery [LAD] / non-LAD / right coronary artery [RCA] / left circumflex artery [LCX]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of>=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. | Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR in each coronary territory. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading performed. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was retrospective analysis. | Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. | Participants in FAS without significant CAD (defined as QCA stenosis of >= 50% by) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed. | Posted | | Number | | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading, | Posted | | Number | | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
|---|
| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment | Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was retrospective analysis. | Participants in FAS without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading. | Posted | | Number | | Specificity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment | Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). | Participants in FAS with significant LMS stenosis indicating significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Count of Participants | | Participants | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative). | Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR. | Posted | | Number | 95% Confidence Interval | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS with single-vessel disease indicating significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator | Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers. | Participants in FAS with multi-vessel disease indicating significant CAD (defined as QCA stenosis of >=70%) as verified by SoR. | Posted | | Number | | Sensitivity % | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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| Secondary | Number of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessment | Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI. | | Posted | | Count of Participants | | Participants | | 0 to 30/40 min post-injection | | | | ID | Title | Description |
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| OG000 | Gadobutrol 0.1 mmol/kg Body Weight | Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector. |
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