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Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD) (GadaCAD 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01890434
Recruitment Status : Completed
First Posted : July 1, 2013
Results First Posted : May 16, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis
Actual Study Start Date : August 26, 2013
Actual Primary Completion Date : August 6, 2016
Actual Study Completion Date : November 10, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol

Arm Intervention/treatment
Experimental: 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.
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
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 Outcome Measures :
  1. Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  2. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  3. Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  4. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  5. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  6. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.


Secondary Outcome Measures :
  1. Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  2. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  3. Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  4. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  5. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  6. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  7. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  8. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  9. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  10. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  11. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  12. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  13. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  14. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  15. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  16. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  17. Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment [ Time Frame: 0 to 30/40 min post-injection ]
    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%).

  18. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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).

  19. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  20. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.

  21. 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 [ Time Frame: 0 to 30/40 min post-injection ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged ≥18 years
  • Subjects with suspected or known CAD based on signs and/or (typical or atypical) chest pain who have routine CA without intervention within plus/minus 4 weeks of gadobutrol-enhanced CMRI or subjects at low risk of CAD with / or scheduled to get a CTA for the purpose of exclusion of CAD within plus/minus 6 weeks of gadobutrol-enhanced CMRI
  • Willingness to undergo unenhanced wall motion and gadobutrol-enhanced CMRI at stress/rest and gated single photon emission computed tomography (GSPECT, if GSPECT will be a study procedure)
  • Women of childbearing potential (e.g. age < 60y, no history of surgical sterilization or hysterectomy): use of contraception and a negative pregnancy test
  • Subjects who are scheduled for / have undergone routine GSPECT or undergo GSPECT as a study procedure at stress and at rest within ± 4 weeks of gadobutrol-enhanced CMRI

Exclusion Criteria:

  • Suspected clinical instability or unpredictability of the clinical course during the study period
  • Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
  • History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents according to the investigator's assessment / judgment
  • Estimated glomerular filtration rate (eGFR) value <30 mL/min/1.73 m^2 derived from a serum / blood creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment.
  • Acute renal insufficiency
  • Coronary artery bypass grafting (CABG)
  • Acute myocardial infarction (< 14 days prior to inclusion), unstable angina / acute coronary syndrome, severe congestive heart failure
  • Irregular heart rhythm
  • Condition that precludes the safe administration of pharmacological stressor according to the respective approved label such as sinus node disease, 2nd or 3rd degree atrioventricular block, obstructive lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890434


Locations
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United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Los Angeles, California, United States, 90048-0750
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611-2908
United States, Maryland
Bethesda, Maryland, United States, 20814
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Charlottesville, Virginia, United States, 22908
Australia, South Australia
Adelaide, South Australia, Australia, 5042
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Australia
Chermside, Australia, 4032
North Adelaide, Australia, 5006
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Montreal, Quebec, Canada, H4A 3J1
Singapore
Singapore, Singapore, 168752
Singapore, Singapore
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01890434    
Other Study ID Numbers: 15962
2013-000066-11 ( EudraCT Number )
First Posted: July 1, 2013    Key Record Dates
Results First Posted: May 16, 2018
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Myocardial Perfusion Imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases