check_circleStudy Completed

Coronary Artery Disease

Bayer Identifier:

15962

ClinicalTrials.gov Identifier:

NCT01890434

EudraCT Number:

2013-000066-11

EU CT Number:

Not Available
Gadobutrol / Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD)

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
478
Trial Dates
August 2013 - November 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Montreal, H1T 1C8, Canada
Completed
London, N6A 5A5, Canada
Completed
Bethesda, 20892, United States
Completed
Chicago, 60611-2908, United States
Withdrawn
Los Angeles, 90095-7206, United States
Completed
Cleveland, 44195, United States
Completed
Philadelphia, 19104, United States
Completed
Boston, 02114, United States
Completed
Charlottesville, 22908, United States
Withdrawn
Salt Lake City, 84132, United States
Withdrawn
New Haven, 06520--804, United States
Withdrawn
Minneapolis, 55455, United States
Completed
St. Louis, 63110, United States
Completed
Perth, 6000, Australia
Completed
North Adelaide, 5006, Australia
Completed
Chermside, 4032, Australia
Completed
Adelaide, 5042, Australia
Withdrawn
Toronto, M5G 2N2, Canada
Completed
Los Angeles, 90048-0750, United States
Withdrawn
Tulsa, 74133, United States
Completed
Tucson, 85724, United States
Completed
Houston, 77030, United States
Completed
Singapore, Singapore
Completed
Singapore, 168752, Singapore
Completed
Durham, 27710, United States
Completed
Bethesda, 20814, United States
Withdrawn
Baltimore, 21287-4010, United States
Completed
Columbus, 43210, United States
Completed
Charleston, 29425, United States
Completed
Atlanta, 30322, United States
Completed
Montreal, H4A 3J1, Canada

Primary Outcome

  • 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 QCA (quantitative coronary angiography) 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
    enhanced_encryption
    Safety Issue:
    No
  • Presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI – addtional 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
    enhanced_encryption
    Safety Issue:
    No
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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). Specifity was displayed for all 3 blinded readers and the investigator.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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%).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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).
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection
  • 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.
    date_rangeTime Frame:
    0 to 30/40 min post-injection

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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