Trial Condition(s):
Coronary artery disease
Gadobutrol / Gadavist-enhanced cardiac magnetic resonance imaging (CMRI) to detect Coronary Artery Disease (CAD) (GadaCAD 2)
Bayer Identifier:
15962
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
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).
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
Trial Summary
Enrollment Goal
478
Trial Dates
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Montreal, Canada, H1T 1C8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 5A5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bethesda, United States, 20892 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611-2908 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44195 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlottesville, United States, 22908 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perth, Australia, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site North Adelaide, Australia, 5006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chermside, Australia, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90048-0750 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 168752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bethesda, United States, 20814 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30322 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H4A 3J1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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’ assessmentBlinded 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).Timeframe: 0 to 30/40 min post-injection
- Presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI – addtional secondary analysis of sensitivity based on blinded readers’ assessmentBlinded 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.Timeframe: 0 to 30/40 min post-injection
- Absence of myocardial perfusion defect excluding significant CAD per participant on gadobutrol-enhanced CMRI – primary analysis of specificity based on blinded readers’ assessmentBlinded 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).Timeframe: 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’ assessmentBlinded 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.Timeframe: 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' assessmentPresence 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).Timeframe: 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' assessmentPresence 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.Timeframe: 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 assessmentThe 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).Timeframe: 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 assessmentThe 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.Timeframe: 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 assessmentThe 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).Timeframe: 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 assessmentThe 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.Timeframe: 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 assessmentPresence 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).Timeframe: 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 assessmentPresence 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.Timeframe: 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 assessmentPresence 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).Timeframe: 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 assessmentPresence 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.Timeframe: 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 assessmentAbsence 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).Timeframe: 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 assessmentAbsence 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.Timeframe: 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 assessmentSensitivity 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.Timeframe: 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 assessmentSensitivity 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.Timeframe: 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 assessmentSensitivity 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.Timeframe: 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 assessmentSpecificity 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.Timeframe: 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 assessmentSpecificity 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.Timeframe: 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 assessmentSpecificity 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.Timeframe: 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 assessmentNumber 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%).Timeframe: 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 assessmentSensitivity 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).Timeframe: 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 investigatorSensitivity 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.Timeframe: 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 investigatorSensitivity 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.Timeframe: 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 assessmentScore 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.Timeframe: 0 to 30/40 min post-injection
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