Phase 2
N=232
Myocardial Perfusion MRI
Myocardial Perfusion Imaging · Magnetic Resonance Imaging
Bottom Line
View on ClinicalTrials.gov: NCT01490294 ↗Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions — 58.8; 44.1; 36.7; 40.3 Percent regional assessments
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gadobutrol (Gadavist,Gadovist, BAY86-4875) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions |
58.8; 44.1; 36.7; 40.3; 41.2; 55.9 | — |
| PRIMARY Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments |
51.1; 39.4; 34.5; 34.1; 48.9; 60.6 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions |
48.5; 39.2; 35.2; 37.7; 51.5; 60.8 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments |
39.3; 30.4; 28.7; 33.3; 60.7; 69.6 | — |
| SECONDARY Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions |
81.3; 80.6; 83.3; 86.5; 18.8; 19.4 | — |
| SECONDARY Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments |
88.4; 85.7; 82.0; 90.8; 11.6; 14.3 | — |
| SECONDARY Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions |
81.8; 76.0; 76.5; 85.7; 18.2; 24.0 | — |
| SECONDARY Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments |
86.4; 84.8; 69.7; 88.0; 13.6; 15.2 | — |
| SECONDARY Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions |
87.9; 69.3; 64.4; 60.6; 12.1; 30.7 | — |
| SECONDARY Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments |
91.8; 77.5; 74.3; 68.9; 8.2; 22.5 | — |
| SECONDARY Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions |
63.5; 61.5; 48.3; 46.7; 36.5; 38.5 | — |
| SECONDARY Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments |
77.4; 66.7; 58.4; 58.2; 22.6; 33.3 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions |
67.4; 57.3; 46.8; 53.0; 32.6; 42.7 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments |
53.8; 42.7; 36.8; 37.3; 46.2; 57.3 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions |
52.3; 49.1; 42.1; 46.5; 47.7; 50.9 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments |
40.9; 33.0; 31.1; 35.6; 59.1; 67.0 | — |
| SECONDARY Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions |
66.2; 53.8; 51.4; 53.5; 33.8; 46.2 | — |
| SECONDARY Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments |
48.5; 41.2; 35.6; 35.3; 51.5; 58.8 | — |
| SECONDARY Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments |
1.8; 1.4; 2.8; 1.5; 66.3; 62.7 | — |
| SECONDARY Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments |
85.5; 85.3; 81.5; 83.5; 14.5; 14.7 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses |
50.6; 48.1; 38.8; 32.3; 49.4; 51.9 | — |
| SECONDARY Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions) |
53.7; 40.7; 60.3; 56.7; 46.3; 59.3 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions |
62.8; 51.4; 53.6; 40.7; 37.2; 48.6 | — |
| SECONDARY Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions |
62.1; 60.8; 59.1; 66.0; 37.9; 39.2 | — |
| SECONDARY Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments |
69.6; 57.0; 48.9; 49.4; 30.4; 43.0 | — |
| SECONDARY Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions |
56.3; 55.2; 49.1; 58.3; 43.7; 44.8 | — |
| SECONDARY Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments |
53.0; 46.3; 41.8; 43.7; 47.0; 53.7 | — |
| SECONDARY Signal Intensity (SIrel) Based on Segments |
0.768; 0.625; 0.708; 0.615; 0.732; 0.603 | — |
| SECONDARY Upslope Based on Segments |
11.44; 18.18; 27.49; 31.31; 11.41; 17.90 | — |
| SECONDARY Time to Peak Based on Segments |
12.43; 13.83; 13.87; 15.34; 12.11; 13.67 | — |
| SECONDARY Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions |
0.0; 1.4; 14.3; 36.5; 0.0; 5.6 | — |
| SECONDARY Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments |
0.0; 0.7; 18.9; 31.3; 0.0; 2.7 | — |
| SECONDARY Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions |
6.3; 4.2; 21.4; 25.0; 6.3; 4.2 | — |
| SECONDARY Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments |
4.7; 2.0; 21.6; 23.1; 7.0; 2.0 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) |
5; 12; 11; 8; 0; 1 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) |
1; 4; 1; 4; 0; 4 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) |
3; 11; 14; 14; 0; 5 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) |
1; 6; 2; 3; 2; 3 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) |
3; 8; 15; 17; 0; 4 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) |
2; 5; 2; 4; 2; 4 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) |
5; 11; 15; 18; 0; 4 | — |
| SECONDARY Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) |
4; 3; 1; 3; 1; 5 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) |
5; 11; 13; 8; 0; 2 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS) |
2; 3; 3; 4; 0; 5 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS) |
4; 13; 13; 15; 0; 5 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) |
1; 5; 3; 3; 1; 5 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) |
4; 11; 13; 15; 0; 2 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) |
3; 4; 3; 4; 1; 5 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS) |
5; 12; 12; 14; 0; 4 | — |
| SECONDARY Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS) |
4; 2; 2; 3; 1; 5 | — |
| SECONDARY Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions |
12.1; 21.2; 27.5 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments |
7.3; 27.1; 23.8 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments |
41.7; 75.0; 82.4; 100.0 | — |
| SECONDARY Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions |
20.0; 72.7; 87.5; 92.9 | — |
| SECONDARY Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) |
23.9; 22.3; 26.7; 26.2; 25.3; 19.4 | — |
| SECONDARY Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) |
26.8; 24.9; 21.3; 11.7; 23.3; 21.3 | — |
| SECONDARY Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) |
86.5; 76.7; 76.8; 85.2; 13.5; 23.3 | — |
Summary
The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.
For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.
The total imaging time is about 45 min.
Eligibility Criteria
Inclusion Criteria
- Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
- The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only
Exclusion Criteria
- Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
- Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
- Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
- Non-sinus rhythm
- Sinus node disease or symptomatic bradycardia
- Second or third degree atrial ventricular (AV) block
- Complete left bundle branch block (LBBB)
- Known congenital long QT syndrome or a family history of congenital long QT syndrome
- Known previous arrhythmias on drugs that prolong cardiac repolarization
- Uncorrected hypokalemia
- Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
- Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
- Ejection fraction below 35%
- Cardiomyopathy, congenital heart defect or higher degree valvular pathology
- Coronary artery stent placement within 4 weeks prior to the MRI procedure
- Previous heart transplantation
Data sourced from ClinicalTrials.gov (NCT01490294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.