Myocardial Perfusion MRI
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01490294
First received: July 28, 2011
Last updated: May 24, 2012
Last verified: May 2012
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Results First Received: December 23, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic |
| Conditions: |
Myocardial Perfusion Imaging Magnetic Resonance Imaging |
| Intervention: |
Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
Participant Flow: Overall Study
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | |
|---|---|---|---|---|
| STARTED | 58 | 60 | 59 | 55 |
| Participant Received Treatment | 54 | 60 | 58 | 54 |
| COMPLETED | 53 | 60 | 58 | 54 |
| NOT COMPLETED | 5 | 0 | 1 | 1 |
| Prematurely discontinuation | 4 | 0 | 1 | 1 |
| Adverse Event | 1 | 0 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. |
| Total | Total of all reporting groups |
Baseline Measures
| Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875) | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
54 | 60 | 58 | 54 | 226 |
|
Age
[1] [units: Years] Median ( Full Range ) |
62.0
( 29 to 78 ) |
61.5
( 32 to 83 ) |
64.5
( 39 to 81 ) |
61.0
( 35 to 79 ) |
62.0
( 29 to 83 ) |
|
Gender
[units: Participants] |
|||||
| Female | 15 | 19 | 17 | 19 | 70 |
| Male | 39 | 41 | 41 | 35 | 156 |
|
History of myocardial infarction
[units: Participants] |
|||||
| No | 34 | 42 | 43 | 37 | 156 |
| Yes | 20 | 17 | 15 | 15 | 67 |
| Unknown | 0 | 1 | 0 | 2 | 3 |
| [1] | The study was planned and conducted to provide data for 4 different increasing doses of Gadobutrol. Therefore, the age was not calculated over all four dose groups of Gadobutrol. |
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Outcome Measures
| 1. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 2. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 3. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 4. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 5. Secondary: | Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 6. Secondary: | Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 7. Secondary: | Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 8. Secondary: | Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 9. Secondary: | Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 10. Secondary: | Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 11. Secondary: | Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 12. Secondary: | Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 13. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 14. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 15. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 16. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 17. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 18. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 19. Secondary: | Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 20. Secondary: | Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 21. Secondary: | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 22. 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) [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 23. Secondary: | Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 24. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 25. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 26. Secondary: | Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 27. Secondary: | Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 28. Secondary: | Signal Intensity (SIrel) Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 29. Secondary: | Upslope Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 30. Secondary: | Time to Peak Based on Segments [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes ] |
| 31. Secondary: | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 32. Secondary: | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 33. Secondary: | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 34. Secondary: | Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 35. Secondary: | Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] |
| 36. 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] |
| 37. 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] |
| 38. 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] |
| 39. 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] |
| 40. 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] |
| 41. 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] |
| 42. 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] |
| 43. 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] |
| 44. 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) [ Time Frame: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration ] |
| 45. 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] |
| 46. 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) [ Time Frame: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration ] |
| 47. 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] |
| 48. 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) [ Time Frame: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration ] |
| 49. 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] |
| 50. 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) [ Time Frame: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration ] |
| 51. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 52. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 53. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 54. 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 [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |
| 55. Secondary: | Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading) [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 56. Secondary: | Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation) [ Time Frame: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration ] |
| 57. Secondary: | Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation) [ Time Frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration ] |